NCT03622489

Comparing Protocols for Analgesia Following Elective Cesarean Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia: 1. Scheduled doses of IV acetaminophen + PO Ibuprofen 2. Scheduled doses of PO acetaminophen + PO Ibuprofen 3. "On demand" doses of acetaminophen, dipyrone and ibuprofen.

Detailed description

A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores. Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs. Number of participants: 120 Treatment: All women will receive immediately after surgery, in the recovery room: 1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3 2. IV Tramal 100 mg, once After Admitted to Mternity ward: * 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr * 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr * 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS\>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS\>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. \- 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score: * Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses. * PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses. * Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.

Conditions

• Postoperative Pain
• Post-Cesarean Section

Interventions

Type	Name	Description
DRUG	Acetaminophen	mentioned above
DRUG	Ibuprofen 400 mg	mentioned above
DRUG	Dipyrone	mentioned above
DRUG	Tramadol	mentioned above
DRUG	Morphine	mentioned above
DRUG	Tramal	mentioned above

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2018-08-09
• Last updated: 2018-08-09

Locations

1 site across 1 country: Israel