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

Postoperative Pain Score Clinical Trial

Official title:

Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259243
• Other study ID #: RAJLAPGYNE
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2017
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Score

Intervention

Drug:
• Bupivacaine Hydrochloride
0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection

Locations

Country	Name	City	State
Thailand	Waetasleem Chema	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain after surgery	Postoperative pain score in intervention and placebo groups	24-48 hours after surgery
Secondary	Among of pethidine use	Among of pethidine use to reduced postoperative pain	within 48 hours
Secondary	Duration of hospital stay	Duration of hospital stay after surgery	within 7 days