Clinical trial NCT03796403: 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
Overall status: TERMINATED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2019-01-08
Enrollment: 140
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative pain relief
timeFrame: During acute post operation peroid as 24 hours post operation
Secondary outcomes:
measure: Morphine requirement
timeFrame: During acute post operation period as 24 hours post operation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Suphet Tuipae, MD
role: PRINCIPAL_INVESTIGATOR
References: