After Total hip replacement surgery measures of pain relief are compared between two nerve blocks : Erector spinae plane block vs Quadratus lumborum block

Completed

• Conditions: Medical and Surgical, (2) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip,

• Registration Number: CTRI/2022/05/042394
• Lead Sponsor: Dr Paridhi Jain

Brief Summary

In this study, “COMPARISON OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE

BLOCK AND QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN

TOTAL HIP REPLACEMENT SURGERY – A PROSPECTIVE, RANDOMIZED, DOUBLE

BLINDED STUDYâ€, the analgesic efficacy of ultrasound guided erector spinae plane block and quadratus

lumborum block, as part of multimodal analgesia, will be compared using single shot

0.2% Ropivacaine (25cc) plus Dexamethasone (8mg), following total hip replacement surgery. 70 patients undergoing elective THR

surgery will be included according to the inclusion and exclusion criteria.



Primary objectives:

To determine and compare the analgesic efficacy and duration of analgesia with Lumbar

ESP block and Anterior QL block using Numeric Rating Scale in patients undergoing THR.



Secondary objectives:

1) Time interval after which motor activity will be restored postoperatively and if patients

develop any quadriceps weakness due to the administered block causing delay in

full motor recovery and mobilization.

2) Occurrence of complications like postoperative nausea and vomiting or

hypotension.



Methodology:

Study design: Randomised, double blinded, comparative, prospective study

Place of study: This study will be done in Orthopaedic high dependency unit (HDU) under

department of anaesthesiology in Ganga Medical Centre and Hospital, Coimbatore

Duration of study: 15/04/2022 to 30/06/2022

Sample size: 70 patients, 35 in each group

Study sample: 70 candidates from general population aged 18 to 90 years belonging to either

sex and belonging to ASA I, II or III who will come to our hospital for total hip replacement

and meet the inclusion criteria will be selected for the study.

Patient will be undergoing THR surgery under combined spinal and epidural anaesthesia and they will be

randomised into study groups - Group A (Lumbar-ESPB) and Group B (Anterior-QLB).



After noting the baseline parameters (height, weight, heart rate, blood pressure, saturation), the respective block will be given in the same

lateral position after completion of surgery inside the operation theatre, following which the

patient will be monitored for the next 24 hours. Patient will be followed up at 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8

hr,10 hr,12 hr,18hr and 24 hr (taking the time of block as 0 hrs) and HR, SBP, DBP, oxygen

saturation, NRS score, rescue analgesia requirement and complications or complaints, if any,

will be charted. We will also note the time for motor recovery from neuraxial blockade in terms of

straight leg raise test to 15 degree and dorsiflexion of foot after the surgery. The data thus

obtained, will be analysed to calculate the mean NRS scores, duration of block, time for first

rescue analgesia requirement, time at which patient was able to do active straight leg raise

and dorsiflexion of foot.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-08-18
• Study Start: 2022-10-05
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

ASA I, II & III Patient undergoing Total Hip Replacement surgery.

Exclusion Criteria

Patient not willing for surgery Patient allergic to Local Anesthetic agents Bleeding diathesis , patient on anti platelets Revision Surgery Patient with Hepatic or Renal Failure Body Mass Index more than 40 Patient having pre-existing Peripheral Neuropathy Patient on regular opioids prior to surgery Localised infection at site of Peripheral Nerve block.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative pain score using Numeric Rating Scale	at 30 minutes to 24 hours post operatively

Secondary Outcome Measures

Name	Time	Method
Time interval of motor activity restoration after administered block	At 30 minutes to 24 hours post operatively
Quadriceps weakness due to block causing delay in full motor recovery	At 30 minutes to 24 hours post operatively
Presence of complications like PONV or hypotension	At 30 minutes to 24 hours post operatively

Trial Locations

Locations (1)

Ganga Medical Centre and Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Ganga Medical Centre and Hospital

🇮🇳Coimbatore, TAMIL NADU, India

Dr Paridhi Jain

Principal investigator

9660045494

drparidhi15@gmail.com