to study intraperitoneal use of clonidine(alpha agonist), as additive to local anaesthetic) for postoperative pain relief and sideeffects after abdominal uterus removal

Completed

• Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

• Registration Number: CTRI/2016/12/007544
• Lead Sponsor: Mata Chanan Devi Hospital

Brief Summary

Our objective in this study was to assess the analgesic efficacy and side effects of intraperitoneal clonidine. 60 females were randomly divided into 2 groups. Group I- patients received 3mcq/kg clonidine intravenously at the time of peritoneal closure along with 30ml of  0.25% bupivacaine intraperitoneally as well as at skin incision site. Group II- patients received both 3mcq/kg clonidine and 30 ml of 0.25% bupivacaine intraperitoneally and at skin incision site. Pain scores as well as heart rate, blood pressure, nausea and sedation scores were noted at predetermined intervals. Breakthrough pain was treated with fentanyl i.v. and total opioid dose required was noted. It was hypothesised that the analgesic efficacy and side efffects of intraperitoneal clonidine are similar to intravenous clonidine.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-08
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

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

Inclusion Criteria

• •60 ASA grade I and II female patients •Age between 35 to 60 years •scheduled for elective total abdominal hysterectomy surgery under general anaesthesia.
• •Patient willing to give written informed consent for participation in the study.

Exclusion Criteria

• 1. Patients with – ASA grade 3 or above.
• 2. Age more than 60 yrs or less than 35 yrs.
• 3. Patients with morbid obesity, Raynaud’s disease.
• 4. Patients receiving adrenoreceptor agonists,antagonists, or narcotics before operation.
• 5. Patient’s refusal to participate in the study.
• 6. Known hypersensitivity to the study drug 7) H/o cardiovascular, respiratory, hepatic, renal, neurological or endocrine disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the analgesic efficacy of clonidine in wound infiltration with bupivacaine and to compare the same with Intravenous administration in terms of postoperative analgesic requirement and side-effects (nausea, sedation, bradycardia and hypotension)	for heart rate and blood pressure- at peritoneal closure, 15,30,45,60,90,120 minutes after it. | for pain,sedation,nausea- at post anaesthesia care unit arrival,2,4,6,12,24hours after it

Secondary Outcome Measures

Name	Time	Method
Dose of opioid needed	over first 24 hours.
Time of opioid requirement	noted for first 24 hours postoperatively.

Trial Locations

Locations (1)

Mata Chanan Devi Hospital; 🇮🇳 West, DELHI, India

Mata Chanan Devi Hospital

🇮🇳West, DELHI, India

Dr Divya Gupta

Principal investigator

9990925895

darydivs@yahoo.com