Comparing Protocols for Analgesia Following Elective Cesarean Section

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Post-Cesarean Section

Treatments: Drug: Acetaminophen; Drug: Tramal; Drug: Tramadol; Drug: Ibuprofen 400 mg; Drug: Dipyrone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03622489

0022-17-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women undergoing elective cesarian section

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Tab ibuprofen + IV acetaminophen

Experimental group

Description:

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 Maternity ward: - 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 -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.

Treatment:

Drug: Acetaminophen

Drug: Tramadol

Drug: Morphine

Drug: Ibuprofen 400 mg

Drug: Tramal

Tab Ibuprofen + Tab acetaminophen

Experimental group

Description:

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 Maternity ward: - 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 - 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.

Treatment:

Drug: Acetaminophen

Drug: Tramadol

Drug: Morphine

Drug: Ibuprofen 400 mg

Drug: Tramal

"On demand" analgesia

Experimental group

Description:

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: 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.

Treatment:

Drug: Acetaminophen

Drug: Dipyrone

Drug: Tramadol

Drug: Morphine

Drug: Ibuprofen 400 mg

Drug: Tramal