CTRI Number |
CTRI/2017/05/008605 [Registered on: 19/05/2017] Trial Registered Retrospectively |
Last Modified On: |
19/05/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Quadratus Lumborum Block in Patients Undergoing Renal Transplant Surgery |
Scientific Title of Study
|
Perioperative Analgesic Efficacy of Continuous Quadratus Lumborum Block or Continous Transversus Abdominis Plane Block in Patients Undergoing Renal Transplant Surgery - A Randomized, Double Blind, Controlled Trial |
Trial Acronym |
QL vs TAP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Virender Kumar Mohan |
Designation |
Professor |
Affiliation |
AIIMS New Delhi |
Address |
Room No-5007
5th floor
Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
AIIMS, New Delhi-110029
South DELHI 110029 India |
Phone |
9868397803 |
Fax |
|
Email |
dr_vkmohan@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Virender Kumar Mohan |
Designation |
Professor |
Affiliation |
AIIMS New Delhi |
Address |
Room No-5007
5th floor
Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
AIIMS, New Delhi-110029
South DELHI 110029 India |
Phone |
9868397803 |
Fax |
|
Email |
dr_vkmohan@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Virender Kumar Mohan |
Designation |
Professor |
Affiliation |
AIIMS New Delhi |
Address |
Room No-5007
5th floor
Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
AIIMS, New Delhi-110029
South DELHI 110029 India |
Phone |
9868397803 |
Fax |
|
Email |
dr_vkmohan@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS New Delhi |
Address |
Room No 5011
5th Floor
Teaching Block
Department of Anaesthesiology, pain Medicine and Critical Care
All India Institute of Medical Sciences New Delhi110029
Phone 9654162941 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Virender Kumar Mohan |
AIIMS New Delhi |
Room No 5011
5th Floor
Teaching Block
AIIMS
New Delhi South DELHI |
9868397803
dr_vkmohan@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients posted for Live related Kidney transplantation
Patient may have other comorbidities like diabetes, hypertension, coronary artery disease and on regular dialysis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group I- Ultrasound guided Quadratus Lumborum Block
Group II
Ultrasound Guided Transverses Abdominis Plane (TAP) Block
|
Patient will receive 20ml of 0.35% Ropivacaine as a bolus followed by 0.2% ropivacaine infusion @5ml/hr through the catheter for 48 hours |
Intervention |
Ultrasound Guided Quadratus Lumborum Block |
The patient will be positioned in lateral position keeping the side to be blocked upwards. . After aseptic preparation of the injection site, an ultrasound transducer covered with sterile sheath (curvilinear 2-5 MHz, Sono Site M-Turbo. Bothell, WA, USA) will be placed transversely at the flank immediately cranial to iliac crest. The transducer is then moved dorsally keeping the transverse orientation until quadratus lumborum (QL) muscle is identified with its attachment to the lateral edge of the transverse process of lumbar (L4) vertebral body. With psoas major muscle (PM) anteriorly , erector spinae muscle (ESM) posteriorly and QL muscle ardherent to the apex of the transverse process, a well recognisable pattern of shamrock with three leaves can be seen.(Shamrock pattern). A 18 G epidural needle wil be inserted using in plane technique along the lateral edge of the transduceer.The tip of the needle will be advanced through the QL muscle penetrating the ventral fascia of QL muscle, and after negative aspiration and confirming the needle tip position with hydrodissection, 20 ml of ropivacaine 0.375% will be injected between PM and QL muscle. The multi-orifice catheter will be place and secured through an introducer epidural needle, leaving 5–6 cm of the catheter positioned between quadratus lumborum muscle and psoas major muscle |
Intervention |
Ultrasound Guided Transverses Abdominis Plane (TAP) Block |
Patient will be positioned supine. After aseptic preparation of the injection site, an ultrasound transducer covered with sterile sheath (linear 6–13 MHz, SonoSite M-Turbo. Bothell, WA, USA) will be positioned transversely midway between the iliac crest and the costal margin at level of mid-axillary line. After identifying the anterior abdominal muscles, an 18-G epidural needle will be introduced anteriorly and in the plane of the ultrasound beam until its tip is between the internal oblique and transverse abdominal muscles. After negative aspiration and confirming the needle tip position with hydrodissection, 20 ml of ropivacaine 0.375% will be injected and distribution of the injectate between the internal oblique and transverse abdominal muscles is observed. The multi-orifice catheter will be placed and secured through an introducer epidural needle, leaving 5–6 cm of the catheter positioned between the transverse abdominis and internal oblique muscles. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Scheduled for live related renal transplant |
|
ExclusionCriteria |
Details |
Patients having history of coagulation disorders, antiplatelet therapy, anticoagulant therapy, morbid obesity and any known allergy for Ropivacaine will be excluded from the study |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the intraoperative and postoperative analgesic consumption and postoperative VAS scores |
Visual Analogue Scale (VAS) scores will be noted on the emergence, at 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42 and 48 hr |
|
Secondary Outcome
|
Outcome |
TimePoints |
Incidence of nausea, vomiting, respiratory complication and catheter related complications |
on the emergence, at 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42 and 48 hr |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
17/02/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
1. Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. Case Rep. 2015 Feb 1;4(3):34–6.
2. 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.
3. Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Jul 11;
4. Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550–2.
5. 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. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Patient recruitment will start after ethical committee approval Institute Ethics Committee requires primary registration of trial in CTRI Brief Summary Peri-operative pain management in patients undergoing kidney transplantation is challenging because of impaired renal function and respiratory complications from opioids (1,2). The pharmacokinetics of many drugs is altered including that of opioids, and therefore, the use of morphine for postoperative analgesia after renal transplantation may result in accumulation of its active metabolite; morphine 6-glucuronide due to renal impairment and leads to undesirable side effects, including respiratory depression, hypoxia, and even psychosis (3,4,5,6). The use of non-steroidal anti-inflammatory drugs is avoided after renal transplantation because of their potential adverse effects on renal haemodynamics. Administration of neuraxial anaesthesia is controversial due to the likelihood of platelet dysfunction in these patients and surgical time can be prolonged, leading to conversion to general anaesthesia (7,8,9). Intravenous opioids especially morphine remain the mainstay of analgesia, even though significant accumulation of morphine-6-glucuronide has been observed in transplant patients, despite sufficient primary graft function stopping the need for dialysis after transplantation (10). The combination of intercostal and ilioinguinal–hypogastric nerve blockade has been shown to reduce both postoperative pain and opioid consumption after renal transplant, and a small pilot study of transversus abdominis plane (TAP) block and a retrospective review of the use of a continuous TAP block reported similar results (11,12,13). Transversus abdominis plane block targets the lower six thoracic and first lumbar nerve as they course through the interfascial plane that exists between the transversus abdominis and internal oblique muscles, provides analgesia for procedures involving the abdominal wall. TAP blocks have been used in a number of lower abdominal surgical procedures, with investigators reporting reductions in pain scores and opioid requirements (14,15,16) whereas Frier et al. found no reduction in opioid consumption in patients following renal transplantation (17). Quadratus lumborum (QL) block described by Blanco, is a recently introduced variation of TAP block, reported to provide excellent post-operative analgesia in; pediatric patients undergoing radical nephrectomy (18), colostomy closure (19), pyeloplasty (20) ,and an adult patient undergoing laparotomy for duodenal tumor excision (21). In a radiological study, on the posterior approach of TAP block, which has been described now as the QL block, has shown the spread of the dye and local anaesthetic from T4-L1 (22). QL is an extension of TAP block toward the dorsal region. The US-guided TAP block has the limitation of requiring two levels of block to cover incisions above and below the umbilicus (23). QL block in has an advantage of covering all the dermatome from L2 caudally to T4 cranially as the drug is expected to spread cranially to the higher paravertebral spaces (22). Carney et al (22), described that the contrast solution placed posteriorly accumulates near the lateral border of the QL and then spreads in a posterior-cranial fashion to the anterior aspect of the QL and psoas major to lie at the paravertebral space. They also obseved the contrast enhancement from T4-L2 level. Similar spread of contrast with a single bolus to cover the incisions above and below the umblicus has been demonstrated by McDonnell et al (16). There are no studies in the literature evaluating the analgesic efficacy of quadratus lumborum block for abdominal and renal transplant surgery. This study has been designed to compare the perioperative analgesic efficacy of continuous quadratus lumborum block with the continuous TAP block in a patients scheduled for renal transplant surgery. We hypothesized that a preincisional continuous quadratus lumborum (QL) block will provide a better perioperative analgesia as compared to continuous transeversus abdominis plane (TAP) block and reduced opioid consumption in the postoperative period in patients undergoing renal transplant. |