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

Not Applicable

Terminated

• Conditions: Post-operative Pain
• Interventions: Other: Diclofenac

• Registration Number: NCT03796403
• Lead Sponsor: Rajavithi Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-28
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Study Start: 2019-02-15
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diclofenac and bupivacaine group	Diclofenac	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.
bupivacaine only group	Diclofenac	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain relief	During acute post operation peroid as 24 hours post operation	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

Name	Time	Method
Morphine requirement	During acute post operation period as 24 hours post operation	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.

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand