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

Rajavithi Hospital

Status: Terminated

Conditions: Post-operative Pain

Treatments: Other: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03796403

Suphetgyn2516

Details and patient eligibility

About

compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

diclofenac and bupivacaine group

Experimental group

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.

Treatment:

Other: Diclofenac

bupivacaine only group

Placebo Comparator group

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.

Treatment:

Other: Diclofenac