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Clinical Trials/NCT03259243
NCT03259243
Completed
Phase 4

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

Rajavithi Hospital1 site in 1 country100 target enrollmentApril 1, 2017

Overview

Phase
Phase 4
Intervention
Bupivacaine Hydrochloride
Conditions
Postoperative Pain Score
Sponsor
Rajavithi Hospital
Enrollment
100
Locations
1
Primary Endpoint
Postoperative pain after surgery
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
January 31, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Bupivacaine Hydrochloride

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

Intervention: Bupivacaine Hydrochloride

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

Intervention: Bupivacaine Hydrochloride

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

Intervention: Bupivacaine Hydrochloride

Outcomes

Primary Outcomes

Postoperative pain after surgery

Time Frame: 24-48 hours after surgery

Postoperative pain score in intervention and placebo groups

Secondary Outcomes

  • Among of pethidine use(within 48 hours)
  • Duration of hospital stay(within 7 days)

Study Sites (1)

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