CTRI Number |
CTRI/2025/05/086596 [Registered on: 08/05/2025] Trial Registered Prospectively |
Last Modified On: |
07/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Comparision of an anaesthetic drug and a nerve block to study better postoperative pain relief. |
Scientific Title of Study
|
To compare the effictiveness of ultrasound guided Quadratus lumborum block using injection bupivacaine and intravenous tramadol for postoperative analgesia in unilateral renal surgeries- A randomised comparative study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Karumuri Venkata Jayabala |
Designation |
Junior Resident |
Affiliation |
Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. |
Address |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.
Indore MADHYA PRADESH 452001 India |
Phone |
6281017699 |
Fax |
|
Email |
jayabala.karumuri@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepali Valecha |
Designation |
Assistant Professor |
Affiliation |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. |
Address |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.
Indore MADHYA PRADESH 452001 India |
Phone |
9424405405 |
Fax |
|
Email |
deepalisidhwani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Deepali Valecha |
Designation |
Assistant Professor |
Affiliation |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. |
Address |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.
Indore MADHYA PRADESH 452001 India |
Phone |
9424405405 |
Fax |
|
Email |
deepalisidhwani@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical college and M.Y.Hospital, Indore, Madhya Pradesh, India. Pincode 452001 |
|
Primary Sponsor
|
Name |
Mahatma Gandhi Memorial Medical college and MYHospital |
Address |
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical college and M.Y.Hospital, Indore, Madhya Pradesh, India. Pincode 452001 |
Type of Sponsor |
Government medical college |
|
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 |
Karumuri Venkata Jayabala |
Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh |
Ground floor, Operation theatre Complex, Department of Anaesthesiology office, M.Y.Hosoital, Indore, Madhya Pradesh, India. Pincode 452001. Indore MADHYA PRADESH |
6281017699
jayabala.karumuri@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics and Scientific Review committee, M.G.M Medical college & M.Y.Hospital, Indore. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Injection tramadol 1.5mg per kg |
At the end of surgery other group of patients will receive injection tramadol 1.5mg per kilogram for post operative analgesia in unilateral renal surgery patients as a single bolus intravenous administration. |
Intervention |
Quadratus lumborum block using injection Bupivacaine |
At the end of surgery and before extubation one group of patients are given Quadratus lumborum block for post operative analegesia in unilateral renal surgeries patient using injection bupicacaine 0.25% 25ml as a single bolus injection. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Informed consent, Physical status ASA I, II, III and age group between 18 to 65 years |
|
ExclusionCriteria |
Details |
Patient refusal, Any contraindications to regional anaesthesia and those who are allergic to local anaesthesia, Patients with coagulation abnormalities, obese patients with BMI more than 29.9 kg/m2. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To compare the duration of postoperative analgesia in two groups. |
To compare the duration of postoperative analgesia in two groups upto 24 hours at different time intervals. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the total consumption of analgesia in the first 24 hours. |
Total analgesic requirement in both groups will be monitored upto 24 hours postoperatively at different time intervals depending on patient complaints. |
To assess complications or side effects if any. |
To assess for complications like nausea, vomiting, hypotension, bradycardia if any within 24 hours postoperatively any time if they occur within 24 hours. |
|
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
|
Phase 4 |
Date of First Enrollment (India)
|
18/05/2025 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
INTRODUCTION Despite advances in both surgical and anaesthesia techniques, post operative pain remains an important concern in patients undergoing renal surgeries. The postoperative pain following surgical procedures not only prolongs the duration of hospital stay but also increases morbidity and effect enhanced recovery programs. Peripheral nerve blocks and interfascial plane blocks are considered safer, providing long lasting analgesia as compared to central neuraxial blockade, and systemic analgesia (i/v, oral) facilitating lesser morbidity and early discharges. Main advantage of Quadratus lumborum block is that it provides higher dermatome coverage (T6-L1), better sensory coverage and visceral analgesia.The ultrasound is a valuable adjunct in peripheral nerve block practice due to clarity and direct visualisation of anatomical landmarks providing better and long lasting blockage with lesser complications. Hence, this study aims to evaluate the analgesic efficacy of ultrasound guided Quadratus lumborum block for postoperative analgesia in patients undergoing unilateral renal surgeries. METHODOLOGY The day before surgery pre anaesthetic assessment of all patients will be done and all the patients will be explained about the NBM period, visual analogue scale (VAS score) and study protocol in their local vernacular language and written informed consent will be obtained for the same. Patients will be divided into two groups by odd and even method (30 in each group). Patients in group A will be given ultrasound guided quadratus lumborum block and patients in group B will be given Inj. Tramadol 1.5mg/kg as analgesic at the end of surgery. General anaesthesia will be standardised to all patients. Inj.Fentanyl 1mcg/kg will be administered as a top up after 60 minutes from onset of surgery. At the end of surgery, patients of Group A will receive Quadratus lumborum block (type: anterior Shamrock’s approach) in lateral position using an ultrasound machine with a curvilinear 2-5 MHz probe using Inj. Bupivacaine 0.25% 25ml. Patients of Group B will receive Inj.Tramadol 1.5mg/kg at the end of surgery. Haemodynamic parameters of the patient will be monitored at every 5 minutes interval till 20 minutes after giving the block and then every 20 minutes till 2 hours. After extubation, the pain will be assessed by the VAS scale of 1-10, 30 minutes post procedure till 2 hour, then at 4, 8, 12, 18, 24 hour. The patients will be administered Inj.Tramadol 1.5mg/kg if their VAS score >3 and the time duration from administration of block to VAS > 3 will be considered as duration of analgesia. The patients will be monitored from the time of extubation to 24 hours postoperatively and total consumption of Inj. Tramadol in this period will be noted. The incidence of adverse effects such as nausea, vomiting, hypotension, tachycardia etc., will be noted down and treated accordingly. REFERENCES 1. Venkatraman R, Saravanan R, Mohana KV, Pushparani A. Evaluation of ultrasound guided quadratus lumborum block for postoperative analgesia in unilateral laparoscopic renal surgeries – A randomised controlled trial. Indian J Anaesth 2020;64:1007-11. 2. Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth 2020;64:605-10. 3. Raman R, Prabha R. Quadratus lumborum block for patients undergoing percutaneous nephrolithotomy: A randomized controlled study. Anesth Essays Res 2021;15:174-8. 4. Kerai, Sukhyanti; Saxena, Kirti Nath1. Quadratus lumborum block for post-caesarean analgesia. Indian Journal of Anaesthesia 61(4):p 364, April 2017. | DOI: 10.4103/ija.IJA_220_17 . 5. Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth 2019;63:820- 6. Sindwani G, Sahu S, Suri A, Saeed Z. Bilateral quadratus lumborum block for postoperative analgesia in a Von Hippel-Lindau syndrome patient undergoing laparoscopic radical nephrectomy. Saudi J Anaesth 2017;11:513-4. 7. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol 2015;32:812-8. 8. Blanco R, Ansari T, Riad W, Shetty N. Quadratus lumborum block versus transversus abdominis plane block for postoperative pain after cesarean delivery: A randomized controlled trial. Reg Anesth Pain Med 2016;41:757-62. 9. Krohg A, Ullensvang K, Rosseland LA, Langesæter E, Sauter AR. The analgesic effect of ultrasound-guided quadratus lumborum block after cesarean delivery: A randomized clinical trial. Anesth Analg 2018;126:559-65. 10. Ökmen K, Ökmen BM. Ultrasound-guided anterior quadratus lumborum block for postoperative pain after percutaneous nephrolithotomy: A randomized controlled trial. Korean J Anesthesiol 2020;73:44-50. |