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

Postoperative Pain Clinical Trial

Official title:

Comparison of Ultrasound Guided Quadratus Lumborum Block With Ultrasound Guided TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824939
• Other study ID #: NK/2663/MS/3121-22
• Status: Completed
• Phase: N/A
• First received: June 27, 2016
• Last updated: December 12, 2017
• Start date: September 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Transversus Abdominis Plane (TAP) Block
0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively
• 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

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (19)

Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. Review. — View Citation

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. — View Citation

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. — View Citation

Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-9. — View Citation

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. — View Citation

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. — View Citation

Carvalho R, Segura E, Loureiro MD, Assunção 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. — View Citation

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. — View Citation

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):45 — View Citation

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. — View Citation

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.0b013e31825c16 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Sjövall 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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption in 24 hours in milligrams		within the first 24 hours after surgery
Secondary	Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)		within the first 24 hours after surgery
Secondary	Time to first demand of rescue analgesic in hours		within the first 24 hours after surgery
Secondary	Ease of performing the respective blocks (assessed by time required to perform the blocks in minutes and number of attempts required to perform the blocks)		while performing block
Secondary	Incidence of block related complications		within the first 24 hours after surgery
Secondary	Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)		within the first 24 hours after surgery
Secondary	Patient satisfaction as measured by numeric rating scale (0 to 10)		24 hours after surgery