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

Phase 4

Completed

• Conditions: Postoperative Pain Score
• Interventions: Drug: Bupivacaine Hydrochloride

• Registration Number: NCT03259243
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

Detailed Description

Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.

Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-19
• Study First Submitted QC: 2017-08-19
• Study First Posted: 2017-08-23
• Primary Completion: 2017-10-30
• Study Completion: 2018-01-31
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo group	Bupivacaine Hydrochloride	0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS
Preincision Bupivacaine	Bupivacaine Hydrochloride	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
Preclosure bupivacaine	Bupivacaine Hydrochloride	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
Bupivacaine group	Bupivacaine Hydrochloride	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

Primary Outcome Measures

Name	Time	Method
Postoperative pain after surgery	24-48 hours after surgery	Postoperative pain score in intervention and placebo groups

Secondary Outcome Measures

Name	Time	Method
Among of pethidine use	within 48 hours	Among of pethidine use to reduced postoperative pain
Duration of hospital stay	within 7 days	Duration of hospital stay after surgery

Trial Locations

Locations (1)

Waetasleem Chema; 🇹🇭 Bangkok, Thailand