Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery

NCT03259243 | Completed Phase 4 DMC

• 1 other identifier: RAJLAPGYNE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

Conditions

Postoperative Pain Score

Keywords

Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain after surgery

  Postoperative pain score in intervention and placebo groups

  24-48 hours after surgery

Secondary Outcomes (2)

• Among of pethidine use

  within 48 hours

• Duration of hospital stay

  within 7 days

Study Arms (4)

placebo group

PLACEBO COMPARATOR

0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS

Drug: Bupivacaine Hydrochloride

Preincision Bupivacaine

EXPERIMENTAL

0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS

Drug: Bupivacaine Hydrochloride

Preclosure bupivacaine

EXPERIMENTAL

0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine

Drug: Bupivacaine Hydrochloride

Bupivacaine group

EXPERIMENTAL

0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection

Also known as: 0.5% Marcaine

Bupivacaine group; Preclosure bupivacaine; Preincision Bupivacaine; placebo group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who undergoing gynecologic laparoscopic surgery
• Patient who agrees to participate in this study
• Patient able to speak and understand Thai
• Patient able to complete the questionnaire

You may not qualify if:

• Patient with history of allergy in any kind anesthetic drug
• Patient who pregnant
• Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
• Patient whom the surgery is withhold or canceled
• Patient whom the surgery is converted to laparotomy

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Waetasleem Chema

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 23, 2017
• Study Start: April 1, 2017
• Primary Completion: October 30, 2017
• Study Completion: January 31, 2018
• Last Updated: October 22, 2020

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)