Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy

NCT ID: NCT02824939

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-05-31

Brief Summary

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This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy.

To fulfill this purpose, three groups of patients each with 32 patients, will be formed. Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion of surgery. The third (Control group) will not receive any blocks. After shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Transversus Abdominis Plane group

Group Type EXPERIMENTAL

Transversus Abdominis Plane (TAP) Block

Intervention Type OTHER

0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively

Quadratus Lumborum group

Group Type EXPERIMENTAL

Quadratus Lumborum (QL) Block

Intervention Type OTHER

0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transversus Abdominis Plane (TAP) Block

0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively

Intervention Type OTHER

Quadratus Lumborum (QL) Block

0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients between 18-65 years of age,
* ASA class I or II,
* undergoing elective unilateral laparoscopic nephrectomy
* under general anaesthesia

Exclusion Criteria

Patients with any of the following:

* refusal to participate in the study
* coagulopathy/ thrombocytopenia
* localised infection at the proposed site of injection
* inability to comprehend the scoring systems to be employed or use PCA due to physical or mental problems
* known allergy to the drugs to be used (local anesthetics, opioids)
* opioid tolerance/ dependence
* renal impairment
* hepatic impairment
* known cardio-respiratory impairment
* morbid obesity/ sleep apnoea
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Kritika Rathour

Junior Resident, Department of Anaesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status

Countries

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India

References

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Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

Reference Type BACKGROUND
PMID: 9389858 (View on PubMed)

Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.

Reference Type BACKGROUND
PMID: 11207398 (View on PubMed)

Sjovall S, Kokki M, Kokki H. Laparoscopic surgery: a narrative review of pharmacotherapy in pain management. Drugs. 2015 Nov;75(16):1867-89. doi: 10.1007/s40265-015-0482-y.

Reference Type BACKGROUND
PMID: 26493289 (View on PubMed)

Gorevski E, Wead S, Tevar A, Succop P, Volek P, Martin-Boone J. Retrospective evaluation of donor pain and pain management after laprascopic nephrectomy. Transplant Proc. 2011 Sep;43(7):2487-91. doi: 10.1016/j.transproceed.2011.06.038.

Reference Type BACKGROUND
PMID: 21911110 (View on PubMed)

Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

Reference Type BACKGROUND
PMID: 18428988 (View on PubMed)

Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.

Reference Type BACKGROUND
PMID: 23150820 (View on PubMed)

McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

Reference Type BACKGROUND
PMID: 17961838 (View on PubMed)

Barrington MJ, Ivanusic JJ, Rozen WM, Hebbard P. Spread of injectate after ultrasound-guided subcostal transversus abdominis plane block: a cadaveric study. Anaesthesia. 2009 Jul;64(7):745-50. doi: 10.1111/j.1365-2044.2009.05933.x.

Reference Type BACKGROUND
PMID: 19624629 (View on PubMed)

Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344.

Reference Type BACKGROUND
PMID: 19059922 (View on PubMed)

Lee TH, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches to ultrasound-guided transversus abdominis plane block. Anaesth Intensive Care. 2010 May;38(3):452-60. doi: 10.1177/0310057X1003800307.

Reference Type BACKGROUND
PMID: 20514952 (View on PubMed)

De Oliveira GS Jr, Castro-Alves LJ, Nader A, Kendall MC, McCarthy RJ. Transversus abdominis plane block to ameliorate postoperative pain outcomes after laparoscopic surgery: a meta-analysis of randomized controlled trials. Anesth Analg. 2014 Feb;118(2):454-463. doi: 10.1213/ANE.0000000000000066.

Reference Type RESULT
PMID: 24445643 (View on PubMed)

Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

Reference Type RESULT
PMID: 21851346 (View on PubMed)

Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

Reference Type RESULT
PMID: 26225500 (View on PubMed)

Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.

Reference Type RESULT
PMID: 22902793 (View on PubMed)

Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.

Reference Type RESULT
PMID: 26397443 (View on PubMed)

Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.

Reference Type RESULT
PMID: 23927552 (View on PubMed)

Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.

Reference Type RESULT
PMID: 24249997 (View on PubMed)

Carvalho R, Segura E, Loureiro MD, Assuncao JP. [Quadratus lumborum block in chronic pain after abdominal hernia repair: case report]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):107-109. doi: 10.1016/j.bjan.2014.08.001. Epub 2014 Dec 6. Portuguese.

Reference Type RESULT
PMID: 25487690 (View on PubMed)

Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.

Reference Type RESULT
PMID: 25642956 (View on PubMed)

Other Identifiers

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NK/2663/MS/3121-22

Identifier Type: -

Identifier Source: org_study_id