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Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy

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ClinicalTrials.gov Identifier: NCT03879980
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Brief Summary:
Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease inflammation responses of IL-6, and reduce acute pain intensity in comparison with non-receiving QL block as the control group.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bilateral QL block Drug: Non-QL block Not Applicable

Detailed Description:
Quadratus lumborum block had been studied as an effective postoperative analgesia in lower abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive analgesia" on patient underwent laparoscopic living donor nephrectomy has never been evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before and after surgery. Both groups immediately received basic postoperative analgesia regimen paracetamol 1 gr IV 8th hourly.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Forty-four healthy patients with American Society of Anesthesiologists (ASA) classification I or II gave written consent to participate and were randomly allocated into QL block group or control (non-QL block) group. Randomisation used blocks of 4 into 2 groups using a list of random numbers and was performed by sealed envelopes. The surgeries were performed by 3 urology surgeon consultants with comparable distributions. Patients and principal investigator were blinded to group allocation.
Primary Purpose: Supportive Care
Official Title: Effect of Preincisional Ultrasound-guided Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Transperitoneal Laparoscopic Nephrectomy: A Single-Blinded, Randomised Control Trial
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Non-QL block
The control (non-QL block) group only received fentanyl IV during surgery.
Drug: Non-QL block
Only received fentanyl IV during surgery.

Experimental: Bilateral QL block
The patients were in the semi-lateral supine position to show up the side to be blocked. Using USG and 1-6 MHz convex transducer placed in the transverse plane above the iliac crest at the level of the umbilicus. A Stimuplex® 20G 100-mm needle was advanced in anteroposterior direction toward the junction of tapered abdominal muscle layer and QL muscle, and 20 ml of 0.25% bupivacaine was deposited in the anterolateral border of QL muscle at the junction with the transversalis fascia reach outside the anterior layer of transversalis fascia. The lateral approach QL (type I) blocks were performed at both sides of patients. The total amount of bupivacaine was 100 mg for each patient
Drug: Bilateral QL block
Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.




Primary Outcome Measures :
  1. Intraoperative fentanyl consumption [ Time Frame: Intraoperative ]
    Intraoperative fentanyl consumption was recorded as total consumption in µg, and calculated into mean consumption per hour in µg.kg-1.h-1, due to the influence of patients body weight and duration of surgery to the given dose of fentanyl boluses.

  2. Changes in Interleukin-6 from baseline [ Time Frame: 24 hours ]
    Measurement of plasma Interleukin-6 before the anaesthesia induction as the baseline; 2 hours of surgical stimulation and gas insufflation intraoperatively; and 2 hours after recovery from anaesthesia.


Secondary Outcome Measures :
  1. Numerical Rating Scale [ Time Frame: 24 hours ]
    Pain measurement using Numerical Rating Scale (NRS) at rest and during movement. NRS from 0 =no pain to 10= worst pain at 2 hours and 24 hours after anaesthesia recovery

  2. Hemodynamic Profiles: Heart Rate in bpm [ Time Frame: Intraoperative ]
    The trends of perioperative haemodynamic profiles during and after surgery: heart rate in beat per minute

  3. Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg [ Time Frame: Intraoperative ]
    The trends of perioperative haemodynamic profiles during and after surgery : systolic, diastolic and mean arterial pressure in mmHg

  4. Number of participants with additional intravenous tramadol [ Time Frame: 24 hours ]
    During observation after surgery, when the NRS began to increase > 3 at rest the intermittent tramadol 50 mg IV boluses was given 8th hourly. If the NRS still remained > 3, the intermittent tramadol 50 mg IV boluses were administered more frequently up to 4th hourly.

  5. Number of participants with additional intravenous fentanyl [ Time Frame: 24 hours ]
    If the pain relief was still inadequate after increasing tramadol boluses, the extra fentanyl 1 µg.kg^-1 IV boluses was given at every 15-30th minute until the NRS ≤ 3.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 30 kg/m2
  • ASA 1 or 2

Exclusion Criteria:

  • refused to participate
  • chronic use of analgesics or anti-inflammatory drugs
  • allergy to local anaesthetic
  • duration of surgery <4 or > 6 hours
  • duration of anaesthesia <5 or > 7 hours
  • neuropathy

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): NCT03879980


Contacts
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Contact: Dita Aditianingsih, M.D, PhD +628151819244 ditaaditiaa@gmail.com

Locations
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Indonesia
Rumah Sakit Cipto Mangunkusumo Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Dita Aditianingsih, M.D., Ph.D    +628151819244    ditaaditiaa@gmail.com   
Principal Investigator: Dita Aditianingsih, M.D.         
Sponsors and Collaborators
Indonesia University

Publications:
Hayden P, Cowman S. Anaesthesia for laparoscopic surgery. Continuing Education in Anaesthesia, Critical Care & Pain 2011;11(5):177-80.
Moeller-Bertram T, Ky L, Coe C, Strigo I, Kincaid M, Keltner J, et al. Correlation of pain ratings and systemic interleukin-6 release in response to intramuscular capsaicin in healthy Humans. J Pain 2012;13(4):S52.
Blanco R. TAP block under ultrasound guidance: the description of a "no pops" technique [Abstract]. Reg Anesth Pain Med 2007;32:S1-S130.

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Responsible Party: Dita Aditianingsih, Principal Investigator, Head of Intensive Care Unit, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03879980     History of Changes
Other Study ID Numbers: IndonesiaUAnes031
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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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 Dita Aditianingsih, Indonesia University:
quadratus lumborum block
pre-emptive analgesia
laparoscopic nephrectomy

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms