Dexamethasone or Dexmedetomidine : The better helper for post-operative pain relief in femoral nerve blocks

Phase 4

Completed

Conditions: Unilateral primary osteoarthritisof knee,

Registration Number: CTRI/2023/06/054435

Lead Sponsor: fortis hospital mohali

Brief Summary: This study is a double blind prospective randomized control trial to evaluate the analgesic efficacy of dexamethasone and dexmedetomidine, as an adjuvant to 0.375% ropivacaine in ultrasound guided femoral nerve block. This study will be done on 120 ASA [I](https://romannumerals.guide/1) -[II](https://romannumerals.guide/2) patients undergoing unilateral total knee arthroplasty at of Fortis hospital, Mohali. All eligible and consenting patients will be explained VAS score beforehand and given intrathecal 0.5% heavy bupivacaine (dose in range of 2.8-3.4 ml) along with femoral nerve block. Under no circumstances the dose of bupivacaine will exceed 2mg/kg body weight. Patients will be divided between two groups via computer generated randomisation. For femoral nerve block, Group A will receive 8mg dexamethasone with 30ml of 0.375% ropivacaine and group B will receive 1mcg /kg dexmedetomidine with 30ml of 0.375% ropivacaine. The investigator as well as the patient will be blinded about the drug being used. Post operative VAS score and need for rescue analgesia, will be assessed for 24 hours and compared between the two groups. Any adverse effects will also be reported. Based on existing studies using said adjuvants in femoral nerve block, both dexamethasone and dexmedetomidine have been shown to prolong the duration of block and reduce the requirement of opioids. There is a dearth of studies comparing both adjuvants in femoral nerve block, hence our study aims to fill that gap in knowledge. based on similar studies in other blocks, running hypothesis is that both adjuvants provide adequate analgesia but dexamethasone might prove to have a lower over-all VAS score and requirement for rescue analgesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

ASA 1 and 2 consenting to participate able to comprehend and coperate posted for unilateral total knee arthroplasty.

Exclusion Criteria

patient refusal obese patient BMI >35 ASA 3,4 patients with history of OSA or substance abuse, or chronic opiod use.
allergy to local anaesthetic or any drugs used in trial contra-indication to spinal anaesthesia or posted under general anaesthesia patients with hearing or cognitive dysfunction patients on anticoagulants/ history of bleeding disorders pre-existing peripheral neuropathoies.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
average VAS score between the two groups within first 24 hours	0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours

Secondary Outcome Measures

Name	Time	Method
time of first administration of rescue analgesic	within 24 hours
compare the number of patients requiring opioid bolus in the first 24 hours in each group	within 24 hours
to measure the total number of opioid boluses required over the first 24 hours post operatively	within 24 hours
to compare the number of patients amongst each group who report a VAS score of more than or equal to 4 within first 24 hours post operative	0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours

Trial Locations

Locations (1): Fortis Hospital Mohali
🇮🇳
Rupnagar, PUNJAB, India
Fortis Hospital Mohali
🇮🇳Rupnagar, PUNJAB, India
Dr Amolpreet Kaur
Principal investigator
9592047004
kauramolpreet@gmail.com