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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03259243

Enrollment

100

Registered

2017-08-23

Start date

2017-04-01

Completion date

2018-01-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Score

Keywords

Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy

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

Interventions

DRUGBupivacaine Hydrochloride

0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain after surgery	24-48 hours after surgery	Postoperative pain score in intervention and placebo groups

Secondary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026