A clinical trial to compare the effect of clonidine administration by two different routes, intravenous and surgical site infiltration,on pain after gall bladder surgery

Not Applicable

Completed

• Conditions: Post surgical pain

• Registration Number: CTRI/2012/12/003258
• Lead Sponsor: Director

Brief Summary

This randomized double- blind study was conducted to compare the postoperative analgesic effect of clonidine when administered intravenously or in wound infiltration with bupivacaine. 60 adult patients of ASA grade I-II undergoing elective open cholecystectomy were randomly allocated into three groups. Group 1 (control group) patients received wound infiltration with 30 ml 0.25% bupivacaine at the end of surgery. Group 2 patients received 3 mcg/kg clonidine IV plus wound infiltration with bupivacaine, while group 3 patients received 3 mcg/kg clonidine in would infiltration with bupivacaine. Postoperative analgesia was provided with intravenous diclofenac 8 hourly and morphine on demand. The postoperative pain, number of patients requiring rescue analgesia and total morphine consumption during 24 postoperative hours was recorded. Patients were observed for any adverse effects like excessive sedation, nausea-vomiting, hypotension and bradycardia.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-09
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

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

Inclusion Criteria

Patients posted for elective open cholecystectomy under general anesthesia.

Exclusion Criteria

Patients with ASA physical status 3 or 4, Patients with morbid obesity, patients receiving adrenoceptor agonist, antagonist or narcotics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain and analgesic requirement	24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Side effects, like sedation, nausea-vomiting, hypotension and bradycardia	Patients satisfaction score

Trial Locations

Locations (1)

Department of Anesthesia; 🇮🇳 Chandigarh, CHANDIGARH, India

Department of Anesthesia

🇮🇳Chandigarh, CHANDIGARH, India

Neerja Bharti

Principal investigator

9915575145

bhartineerja@yahoo.com