FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Hospital resources 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close