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

Primary Purpose

Postoperative Pain Score

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Score focused on measuring Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Waetasleem Chema

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo group

Preincision Bupivacaine

Preclosure bupivacaine

Bupivacaine group

Arm Description

0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS

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

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

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

Outcomes

Primary Outcome Measures

Postoperative pain after surgery
Postoperative pain score in intervention and placebo groups

Secondary Outcome Measures

Among of pethidine use
Among of pethidine use to reduced postoperative pain
Duration of hospital stay
Duration of hospital stay after surgery

Full Information

First Posted
August 19, 2017
Last Updated
October 20, 2020
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03259243
Brief Title
Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery
Official Title
Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Score
Keywords
Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS
Arm Title
Preincision Bupivacaine
Arm Type
Experimental
Arm Description
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
Arm Title
Preclosure bupivacaine
Arm Type
Experimental
Arm Description
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
Arm Title
Bupivacaine group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
0.5% Marcaine
Intervention Description
0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
Primary Outcome Measure Information:
Title
Postoperative pain after surgery
Description
Postoperative pain score in intervention and placebo groups
Time Frame
24-48 hours after surgery
Secondary Outcome Measure Information:
Title
Among of pethidine use
Description
Among of pethidine use to reduced postoperative pain
Time Frame
within 48 hours
Title
Duration of hospital stay
Description
Duration of hospital stay after surgery
Time Frame
within 7 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Waetasleem Chema
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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