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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 30, 2017

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

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

Arms, Groups and Cohorts

  • 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
  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain after surgery
    • Time Frame: 24-48 hours after surgery
    • Postoperative pain score in intervention and placebo groups

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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