A clinical trial to study the efficacy of local anesthetic drug bupivacaine injected at the site of instrument entry in the abdomen during laparoscopic sterilization in females
- Conditions
- Administration,
- Registration Number
- CTRI/2018/10/015982
- Lead Sponsor
- Dr Aniket Kakade
- Brief Summary
this is a randomized, double blind parallel group trial, comparing the efficacy of infiltration and instillation of local anesthetic drug bupivacaine versus placebo for post operative pain relief after laparoscopic tubal ligation. the drug bupivacaine will be used in dose of 0.25mg/kg of 0.25% solution. 10 ml will be infiltrated at the port site and 20 ml will be instilled intra peritoneal. control group will receive normal saline in same dose. Both group patients will be assessed by a blind assessor every hour by using the visual analogue score [VAS]. rescue analgesia will be administered at VAS 3 when patient complains of pain. any side effects of the drug will also be observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 50
all women who present for laparoscopic tubal ligation.
any intra-operative complication like hematoma formation avulsion of Fallopian tube any allergy to used drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome name: Post operative pain relief. Pain to be assessed by visual analogue score [VAS] Time point: One hourly post operative for 6 hours
- Secondary Outcome Measures
Name Time Method Outcome Name: Side effects of drugs if any Time Points: every one hour for 24 hours
Trial Locations
- Locations (1)
Bharati Hospital & Research Center
🇮🇳Pune, MAHARASHTRA, India
Bharati Hospital & Research Center🇮🇳Pune, MAHARASHTRA, IndiaDr Aniket KakadePrincipal investigator9850988568aniket1kakade@gmail.com