Comparing Protocols for Analgesia Following Elective Cesarean Section

Phase 4

• Conditions: Post-Cesarean Section; Postoperative Pain
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen 400 mg; Drug: Dipyrone; Drug: Tramadol; Drug: Tramal; Drug: Morphine

• Registration Number: NCT03622489
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2018-06
• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"On demand" analgesia	Ibuprofen 400 mg	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.
Tab ibuprofen + IV acetaminophen	Acetaminophen	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.
Tab ibuprofen + IV acetaminophen	Tramal	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.
"On demand" analgesia	Tramadol	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.
Tab ibuprofen + IV acetaminophen	Ibuprofen 400 mg	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.
Tab Ibuprofen + Tab acetaminophen	Ibuprofen 400 mg	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.
"On demand" analgesia	Morphine	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.
"On demand" analgesia	Dipyrone	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.
Tab Ibuprofen + Tab acetaminophen	Acetaminophen	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.
Tab ibuprofen + IV acetaminophen	Tramadol	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.
Tab ibuprofen + IV acetaminophen	Morphine	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.
Tab Ibuprofen + Tab acetaminophen	Tramadol	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.
"On demand" analgesia	Acetaminophen	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.
Tab Ibuprofen + Tab acetaminophen	Morphine	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.
Tab Ibuprofen + Tab acetaminophen	Tramal	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.
"On demand" analgesia	Tramal	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.

Primary Outcome Measures

Name	Time	Method
Average pain score 48 hours following surgery: visual numerical scale (VNS)	48 hours	Using : visual numerical scale (VNS)

Trial Locations

Locations (1)

Wolfson medical center; 🇮🇱 Holon, Israel