Comparision of an anaesthetic drug and a nerve block to study better postoperative pain relief.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/05/086596
• Lead Sponsor: Mahatma Gandhi Memorial Medical college and MYHospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-18
• Last Update Posted: 2025-07-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Informed consent, Physical status ASA I, II, III and age group between 18 to 65 years.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh; 🇮🇳 Indore, MADHYA PRADESH, India

Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh

🇮🇳Indore, MADHYA PRADESH, India

Karumuri Venkata Jayabala

Principal investigator

6281017699

jayabala.karumuri@gmail.com