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TQL-block for Laparoscopic Hemicolectomy

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ClinicalTrials.gov Identifier: NCT03570541
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia.

An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.

Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen.

The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: Acetaminophen Device: Patient controlled analgesia Drug: Morphine Drug: Saline Diagnostic Test: Blood samples Behavioral: Quality of recovery-15 questionaire Diagnostic Test: Orthostatic hypotension Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial.
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Active Comparator: Active

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.

Every six hours postoperative, all patients are administered 1 g of acetaminophen.

In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.

On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.

Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Drug: Ropivacaine
30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks

Drug: Acetaminophen
Every six hours postoperative, all patients are administered 1 g of acetaminophen.

Device: Patient controlled analgesia
PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.

Drug: Morphine
intravenously administered morphine via PCA-pump

Diagnostic Test: Blood samples
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis

Behavioral: Quality of recovery-15 questionaire
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.

Diagnostic Test: Orthostatic hypotension
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Placebo Comparator: Placebo

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.

Every six hours postoperative, all patients are administered 1 g of acetaminophen.

In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.

On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.

Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.

Drug: Acetaminophen
Every six hours postoperative, all patients are administered 1 g of acetaminophen.

Device: Patient controlled analgesia
PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.

Drug: Morphine
intravenously administered morphine via PCA-pump

Drug: Saline
30 ml saline 0,375% administered on each side as bilateral TQL blocks

Diagnostic Test: Blood samples
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis

Behavioral: Quality of recovery-15 questionaire
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.

Diagnostic Test: Orthostatic hypotension
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.




Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: Twenty-four hours postoperative ]
    Data from PCA pump and patient medical record


Secondary Outcome Measures :
  1. Pain during mobilisation [ Time Frame: Registered upon arrival at the postanaesthesia care unit (PACU) and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative. ]
    (Numerical rating scale 0-10/10). No pain = 0, worst pain = 10.

  2. Pain at rest [ Time Frame: Registered upon arrival at the PACU and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative. ]
    (Numerical rating scale 0-10/10). No pain = 0, worst pain = 10.

  3. An integrated assessment of longitudinally measured pain intensity and opioid consumption [ Time Frame: 0-24 hours postoperative ]

    This assessment is calculated using data from outcome 1 and 2. An individual rank for pain intensity using numerical rating scale (0-10/10), 0-24 hours postoperatively and for total opioid consumption 0-24 hours postoperatively will be combined and compared with a mean rank of all patients (active and placebo). The difference between the individual rank and the mean rank will be expressed as a percentage.

    As described by: Andersen LPK, Gögenur I, Torup H, Rosenberg J, Werner MU. Assessment of Postoperative Analgesic Drug Efficacy: Method of Data Analysis Is Critical. Anesth Analg. 2017 Sep;125(3):1008-13.


  4. Morphine consumption [ Time Frame: At 6, 12, 18 postoperative hours. ]
    Data from PCA pump and patient medical record

  5. Duration of block [ Time Frame: Time to first opioid within the first 24 postoperative hours ]
    How long does the TQL block work

  6. The degree of morphine-related side effects. Nausea or post anaesthesia nausea and vomiting (PONV) registered in the case report form, if any. [ Time Frame: 24 hours postoperative ]
    PONV 0-3; 0=No nausea. 3=Unmanageable nausea

  7. Pain upon ambulation (walking 5 meters with aid) [ Time Frame: At 3, 6 and 24 hours postoperative ]
    Evaluated using Numerical rating scale (0-10/10). No pain = 0, worst pain = 10.

  8. Orthostatic hypotension (yes/no) and orthostatic intolerance i.e. symptoms of orthostatic hypotension without a drop in blood pressure (yes/no). [ Time Frame: Before surgery and at 3, 6 and 24 hours postoperative ]
    Evaluated using standardised test regularly used at the Department of Surgery

  9. Quality of Recovery - 15 questionnaire [ Time Frame: Preoperatively and day 1+2 and 10-14 post surgery ]
    The Quality of Recovery -15 questionnaire results in a score of 0-150. Very poor recovery = 0, excellent recovery = 150. These outcome measures will be correlated with changes in immunologic outcome measures in the perioperative period.

  10. Surgical complications [ Time Frame: 30 days post surgery ]
    Classified using the Clavien-Dindo classification

  11. Time to discharge [ Time Frame: 30 days after surgery ]
    Data from the patient medical record

  12. Heart Rate Variability (HRV) [ Time Frame: From block administration and to 24 hours postoperative ]
    On 12 consecutive patients (3 randomization blocks of 4) data will be obtained on heart rate variability using electrocardiography from block administration and the first 24 hours postoperatively. Minimal changes in HRV characterizes differences in sympathetic stress response between the groups

  13. Whole blood gene expression profiling [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    An evaluation of gene expression fold changes compared to POD 0 using an Affymetrix gene expression array. The investigators will specifically measure relative changes in expression of the GZMB gene, which encodes Granzyme B. Granzyme B is expressed by cytotoxic t-cells and NK-cells. The regularized t-test limma will be used to calculate differences in gene expression between samples taken at different time sets, and the Benjamini Hochberg method using the false discovery rate (FDR) will be used to correct for multiple hypothesis testing.

  14. tumor necrosis factor alpha [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to postoperative day (POD) 0.

  15. interleukin-1b [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  16. interleukin -2 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  17. interleukin-6 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  18. interleukin-8 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  19. interleukin-10 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  20. interleukin-11 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  21. interleukin-15 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  22. interleukin-17a [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  23. interleukin-17f [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  24. interleukin-18 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  25. interleukin-22 [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  26. Granulocyte-macrophage colony-stimulating factor [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.

  27. Hemoglobin [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  28. Leucocytes including differential count [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  29. Thrombocytes [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  30. Alanine aminotransferase (ALAT) [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  31. Lactate dehydrogenase [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  32. Bilirubin [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  33. Prothrombin time (International normalized ratio) [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  34. Albumin [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  35. Sodium [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  36. Potassium [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  37. C reactive Protein [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.

  38. Glucose [ Time Frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery ]
    Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Scheduled for laparoscopic or robot assisted hemicolectomy or sigmoidectomy due to colon cancer
  • Have received thorough information, oral and written, and signed the "Informed Consent" form on participation in the trial
  • American Society of Anaesthesiologist physical status classification, class 1-3

Exclusion Criteria:

  • Inability to cooperate
  • Inability to speak and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids (evaluated by the investigators)
  • Drug and/or substance abuse
  • Local infection at the site of injection or systemic infection
  • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
  • Pregnant* or breastfeeding
  • Daily use of oral or intravenous steroids
  • Known immune deficiency (evaluated by the investigators)
  • Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570541


Contacts
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Contact: Jens Børglum, Ph.D.; MD +4530700120 jens.borglum@gmail.com

Locations
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Denmark
Zealand University Hospital, Department of Anaesthesiology Recruiting
Roskilde, Denmark, 4000
Contact: Jens Børglum, Phd    +45 30700120    jedn@regionsjaelland.dk   
Sub-Investigator: Mette Dam, Phd Student         
Sub-Investigator: Christian Hansen, Phd Student         
Sub-Investigator: Martin Vedel, Phd Student         
Principal Investigator: Katrine Tanggaard, Phd Student         
Sub-Investigator: Rune Hasselager, Phd Student         
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Katrine Tanggaard, MD Department of Anaesthesiology, Zealand University Hospital, Roskilde

Publications:
Årsrapporter [Internet]. [cited 2017 Jun 7]. Available from: http://www.dccg.dk/03_Publikation/02_arsraport.html
Børglum J, Moriggl B, Jensen K, Lønnqvist P-A, Christensen AF, Sauter A, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. Br J Anaesth [Internet]. 2013 Apr 22 [cited 2017 May 29];111(eLetters Supplement). Available from: https://academic.oup.com/bja/article/doi/10.1093/bja/el_9919/2451466/Ultrasound-Guided-Transmuscular-Quadratus-Lumborum
Mænchen N. Ultrasound-guided Transmuscular Quadratus Lumborum (TQL) Block for Pain Management after Caesarean Section. [cited 2017 May 29]; Available from: https://clinmedjournals.org/articles/ijaa/international-journal-of-anesthetics-and-anesthesiology-ijaa-3-048.php?jid=ijaa

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03570541     History of Changes
Other Study ID Numbers: SJ-663
2017-005200-96 ( EudraCT Number )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Colon cancer
nerve block
ultra-sound
opioids
surgical stress
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Analgesics, Non-Narcotic
Antipyretics