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Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients

Primary Purpose

Post-operative Pain

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Diclofenac
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy
  • who has scheduled for operation via laparotomy route
  • Women who has ASA physical status I-II
  • All of the have age more than 20 years old
  • able to communicate in Thai
  • Women who agrees to participate in this study

Exclusion Criteria:

  • patient who had emergency conditions - indication for emergency operation
  • intraoperative cardiac arrhythmia
  • operation purpose for only tumor biopsy

    • Women who have abnormal kidney function test (Cr > 1.5)
    • Women with history of gastrointestinal bleeding
    • Women who take the antiplatelet or anticoagulant medications
    • Women with history of allergy to bupivacaine and NSAIDs
    • Women who cannot evaluated pain score

Sites / Locations

  • Rajavithi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

diclofenac and bupivacaine group

bupivacaine only group

Arm Description

Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.

Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.

Outcomes

Primary Outcome Measures

Post-operative pain relief
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.

Secondary Outcome Measures

Morphine requirement
evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.

Full Information

First Posted
September 28, 2018
Last Updated
October 21, 2020
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03796403
Brief Title
Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients
Official Title
Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (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
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
Detailed Description
The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diclofenac and bupivacaine group
Arm Type
Experimental
Arm Description
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
Arm Title
bupivacaine only group
Arm Type
Placebo Comparator
Arm Description
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.
Intervention Type
Other
Intervention Name(s)
Diclofenac
Intervention Description
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
Primary Outcome Measure Information:
Title
Post-operative pain relief
Description
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
Time Frame
During acute post operation peroid as 24 hours post operation
Secondary Outcome Measure Information:
Title
Morphine requirement
Description
evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
Time Frame
During acute post operation period as 24 hours post operation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gynecologic cancer patients
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy who has scheduled for operation via laparotomy route Women who has ASA physical status I-II All of the have age more than 20 years old able to communicate in Thai Women who agrees to participate in this study Exclusion Criteria: patient who had emergency conditions - indication for emergency operation intraoperative cardiac arrhythmia operation purpose for only tumor biopsy Women who have abnormal kidney function test (Cr > 1.5) Women with history of gastrointestinal bleeding Women who take the antiplatelet or anticoagulant medications Women with history of allergy to bupivacaine and NSAIDs Women who cannot evaluated pain score
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suphet Tuipae, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients

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