Effect of starting pain relief before operation on pain after surgery in patients undergoing both knee replacement surgery

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008240
• Date of registration: 28-03-2017
• Prospective Registration: Yes
• Primary sponsor: AIIMS Bhubaneswar
• Public title: Effect of starting pain relief before operation on pain after surgery in patients undergoing both knee replacement surgery
• Scientific title: Effect of pre-emptive epidural analgesia on postoperative pain scores and analgesic requirement in patients undergoing bilateral total knee replacement
• Date of first enrolment: 04-04-2017
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18289
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: P Bhaskar Rao
• Affiliation: AIIMS

• Name: P Bhaskar Rao
• Affiliation: AIIMS

Key inclusion & exclusion criteria

Inclusion criteria: After obtaining written informed consent from patients aged 18 â?? 65 years, of both sex, with either no or controlled systemic illness (American Society of Anesthesiologists physical status I-II), who are planned to undergo elective bilateral total knee replacement will be included.
Exclusion criteria: Patients with history of allergy to local anaesthetics and opioids and history of opioid intake, psychosis, already have been on continued analgesics or corticosteroids 24 h prior to surgery, having contraindications to regional anaesthesia

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: O- Medical and Surgical Health Condition 2: null- patients with both knee joint osteoarthritis posted for knee replacement surgery

Intervention(s)

Intervention1: Group A: Epidural analgesia with infusion of Bupivacaine 0.125% will be started through epidural catheter at evening before surgery. Rate of infusion will be titrated to achieve a pain score of 3 or less.The same will be continued in the postoperative period as well.
Control Intervention1: Group B: Epidural analgesia with 0.125% Bupivacaine will be started only in the postoperative period.

Primary Outcome(s)

analgesic requirement and pain scoresTimepoint: 1. Total 24 hour analgesic requirement after surgery

2. Pain score will be assessed every hour till 4 hours, every 4 hours till 24 hours post-operatively

Secondary Outcome(s)

1. Vital parameters like heart rate and blood pressure

2. length of hospital stayTimepoint: 1. Vital parameters every hour till next 24 hour of surgery

2. days of stay in hospital after surgery

Secondary ID(s)

NIL

Source(s) of Monetary Support

AIIMS, Bhubaneswar

Ethics review

Status: Approved
Approval date: 02/05/2016
Contact:

Institute Ethics Committee, AIIMS, bhubaneswar

Results

• Date Completed: 31/05/2018