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Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03323684
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.


Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Other: Quadratus lumborum block Group (QL) Other: Transversus abdominis plane Group (TAP) Other: Control group (C) Drug: Paracetamol infusion Drug: Ketorolac analgesia Drug: fentanyl Not Applicable

Detailed Description:

The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.

The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 15, 2018

Arm Intervention/treatment
Experimental: Quadratus lumborum block Group (QL)
Quadratus lumborum block will be performed
Other: Quadratus lumborum block Group (QL)
20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Drug: Paracetamol infusion
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Drug: Ketorolac analgesia
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Drug: fentanyl
With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Experimental: Transversus abdominis plane Group (TAP)
Subcostal transversus abdominis plane will be performed
Other: Transversus abdominis plane Group (TAP)
20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Drug: Paracetamol infusion
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Drug: Ketorolac analgesia
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Drug: fentanyl
With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Experimental: Control group (C)
Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac
Other: Control group (C)
No intervention will be done

Drug: Paracetamol infusion
Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Drug: Ketorolac analgesia
In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Drug: fentanyl
With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.




Primary Outcome Measures :
  1. Cumulative postoperative fentanyl consumption (total dose given in micrograms) [ Time Frame: For 24 hours after surgery ]

Secondary Outcome Measures :
  1. Cumulative intraoperative fentanyl consumption (total dose given in micrograms) [ Time Frame: For 4 hours after start of anaesthesia ]
    Cumulative use of fentanyl during intra-operative period

  2. Heart rate [ Time Frame: For 4 hours after start of anaesthesia ]
    Changes in intra-operative heart rate values

  3. Mean arterial blood pressure (mmHg) [ Time Frame: For 4 hours after start of anaesthesia ]
    Changes in intra-operative mean arterial blood pressure values

  4. Dermatomal distribution of the extent of the blockade will be assessed by pinprick method [ Time Frame: the first one hour after surgery ]
    Assessment of dermatomal distribution of the block for evaluating the success or failure of the block

  5. Postoperative pain severity will be assessed using VAS [ Time Frame: For 24 hours after surgery ]
    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain

  6. Time for the first request to rescue analgesia (in minutes) [ Time Frame: For 24 hours after surgery ]
    Time for first request to rescue analgesia

  7. length of stay at PACU (in minutes) [ Time Frame: For 24 hours after surgery ]
  8. Incidence of postoperative nausea and vomiting [ Time Frame: For 24 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Physical Status I or II

Exclusion Criteria:

  • Patient refusal.
  • Hematological diseases
  • bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m2.
  • Emergency laparoscopic cholecystectomy
  • if laparoscopic procedure converted to open.

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): NCT03323684


Locations
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Egypt
Mansoura University, Faculty of Medicine
Mansourah, DK, Egypt, 050
Mansoura University
Mansourah, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Mohamed Y Makharita, MD Professor of Anesthesia and Surgical Intensive Care

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03323684    
Other Study ID Numbers: MD/17.09.09
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Ketorolac
Ketorolac Tromethamine
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action