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

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03796403
• Other study ID #: Suphetgyn2516
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During acute post operation period as 24 hours post operation