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

NCT03796403 | Terminated DMC

• 1 other identifier: Suphetgyn2516
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  During acute post operation peroid as 24 hours post operation

Secondary Outcomes (1)

• Morphine requirement

  During acute post operation period as 24 hours post operation

Study Arms (2)

diclofenac and bupivacaine group

EXPERIMENTAL

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.

Other: Diclofenac

bupivacaine only group

PLACEBO COMPARATOR

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.

Other: Diclofenac

Interventions

Diclofenac OTHER

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 and bupivacaine group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Gynecologic cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Suphet Tuipae, MD

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: January 8, 2019
• Study Start: February 15, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 23, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)