Comparison of analgesic action of two doses of dexmedetomidine, when used in addition to bupivacaine, in femoral nerve block given to reduce post operative pain after total knee replacement surgery

Completed

• Conditions: Unilateral primary osteoarthritisof knee,

• Registration Number: CTRI/2013/11/004168
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Total knee replacement is a very painful procedure, post operative pain impairs early patient mobilization which is the key to the success of the procedure. Dexmedetomidine when used as an adjuvant to local anesthetic agent in peripheral nerve blocks is found to increase duration of the block, in various studies. This adjuvant property of dexmedetomidine is studied in this thesis to provide good quality post operative analgesia in patients undergoing TKR.   This study is a dose comparison study which includes three groups, one control group receiving plain bupivacaine in femoral nerve block, second group receiving 1microgram/kilogram of dexmedetomidine along with bupivacaine in the block. The third group receiving 2microgram/kilogram of dexmedetomidine along with bupivacaine in the block. The post operative pain scores, opioid consumption as well as adverse effects are compared. The data will be statistically analyzed.This is a randomized, controlled, double blinded study. The sample size is sixty.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-08
• Study Completion: 2014-12-31
• Last Update Posted: 2019-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA 1, 2 patients undergoing unilateral primary total knee replacement arthroplasty.

Exclusion Criteria

ASA 3,4, bilateral, revision TKR,focal neurological deficits, pre existing peripheral neuropathy,uncontrolled diabetes mellitus,coagulation disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of post operative analgesia as assessed by,	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia
•pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia
•pain at motion (knee flexion) at 12, 24, 48 hours after surgery	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia
1)VAS (0-10 scale; 0-no pain; 10-worst possible pain)	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia
3)Duration of analgesia: Time to first use of patient controlled analgesia	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia
2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used.	Quality of post operative analgesia as assessed by, | 1)VAS (0-10 scale; 0-no pain; 10-worst possible pain) | •pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery | •pain at motion (knee flexion) at 12, 24, 48 hours after surgery | 2)Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used. | 3)Duration of analgesia: Time to first use of patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
Adverse effects of dexmedetomidine in peripheral nerve block such as nausea, vomiting, pruritus, sedation, hypotension, bradycardia, neuropathy in the perioperative period will be recorded	Adverse effects of dexmedetomidine in peripheral nerve block such as nausea, vomiting, pruritus, sedation, hypotension, bradycardia, neuropathy in the perioperative period will be recorded

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 West, DELHI, India

All India Institute of Medical Sciences

🇮🇳West, DELHI, India

Senthil Packia Sabapathy

Principal investigator

9968889932

ksenps@gmail.com