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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Score
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Waetasleem Chema

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group; 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; 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection; Other Names: 0.5% Marcaine
Experimental: Preincision Bupivacaine; 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; 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection; Other Names: 0.5% Marcaine
Experimental: Preclosure bupivacaine; 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; 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection; Other Names: 0.5% Marcaine
Experimental: Bupivacaine group; 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; 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection; Other Names: 0.5% Marcaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Among of pethidine use	Among of pethidine use to reduced postoperative pain	within 48 hours
Duration of hospital stay	Duration of hospital stay after surgery	within 7 days

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 19, 2017
• First Submitted That Met QC Criteria: August 19, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: RAJLAPGYNE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No