Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Transversus Abdominis Plane (TAP) Block
Quadratus Lumborum (QL) Block
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Post Graduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Transversus Abdominis Plane group
Quadratus Lumborum group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Cumulative morphine consumption in 24 hours in milligrams
Secondary Outcome Measures
Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)
Time to first demand of rescue analgesic in hours
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)
Incidence of block related complications
Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)
Patient satisfaction as measured by numeric rating scale (0 to 10)
Full Information
NCT ID
NCT02824939
First Posted
June 27, 2016
Last Updated
December 12, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02824939
Brief Title
Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversus Abdominis Plane group
Arm Type
Experimental
Arm Title
Quadratus Lumborum group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Transversus Abdominis Plane (TAP) Block
Intervention Description
0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively
Intervention Type
Other
Intervention Name(s)
Quadratus Lumborum (QL) Block
Intervention Description
0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively
Primary Outcome Measure Information:
Title
Cumulative morphine consumption in 24 hours in milligrams
Time Frame
within the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)
Time Frame
within the first 24 hours after surgery
Title
Time to first demand of rescue analgesic in hours
Time Frame
within the first 24 hours after surgery
Title
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)
Time Frame
while performing block
Title
Incidence of block related complications
Time Frame
within the first 24 hours after surgery
Title
Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)
Time Frame
within the first 24 hours after surgery
Title
Patient satisfaction as measured by numeric rating scale (0 to 10)
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9389858
Citation
Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
Results Reference
background
PubMed Identifier
11207398
Citation
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.
Results Reference
background
PubMed Identifier
26493289
Citation
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.
Results Reference
background
PubMed Identifier
21911110
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.
Results Reference
background
PubMed Identifier
18428988
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.
Results Reference
background
PubMed Identifier
23150820
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.
Results Reference
background
PubMed Identifier
17961838
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. doi: 10.1016/j.rapm.2007.03.011.
Results Reference
background
PubMed Identifier
19624629
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.
Results Reference
background
PubMed Identifier
19059922
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.
Results Reference
background
PubMed Identifier
20514952
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. doi: 10.1177/0310057X1003800307.
Results Reference
background
PubMed Identifier
24445643
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):454-463. doi: 10.1213/ANE.0000000000000066.
Results Reference
result
PubMed Identifier
21851346
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.
Results Reference
result
PubMed Identifier
26225500
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.
Results Reference
result
PubMed Identifier
22902793
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.0b013e31825c1697.
Results Reference
result
PubMed Identifier
26397443
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.
Results Reference
result
PubMed Identifier
23927552
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.
Results Reference
result
PubMed Identifier
24249997
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.
Results Reference
result
PubMed Identifier
25487690
Citation
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.
Results Reference
result
PubMed Identifier
25642956
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.
Results Reference
result
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Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
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