Comparing Protocols for Analgesia Following Elective Cesarean Section

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Post-Cesarean Section
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen 400 mg; Drug: Tramadol; Drug: Morphine; Drug: Tramal; Drug: Dipyrone

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lotem Dafna, MD; Phone Number: +972524205415; Email: lotemdafne@yahoo.com

Study Locations

• Israel
  • Holon, Israel
    • Recruiting
    • Wolfson Medical Center
    • Contact: Rinat Hirsh; Phone Number: +97235028346; Email: rinath@wmc.org.il
    • Principal Investigator: Lotem Dafna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tab ibuprofen + IV acetaminophen; All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3; 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.	Drug: Acetaminophen; mentioned above; Drug: Ibuprofen 400 mg; mentioned above; Drug: Tramadol; mentioned above; Other Names: Tramadex; Drug: Morphine; mentioned above; Drug: Tramal; mentioned above
EXPERIMENTAL: Tab Ibuprofen + Tab acetaminophen; All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3; 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.	Drug: Acetaminophen; mentioned above; Drug: Ibuprofen 400 mg; mentioned above; Drug: Tramadol; mentioned above; Other Names: Tramadex; Drug: Morphine; mentioned above; Drug: Tramal; mentioned above
EXPERIMENTAL: "On demand" analgesia; All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3; 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.	Drug: Acetaminophen; mentioned above; Drug: Ibuprofen 400 mg; mentioned above; Drug: Tramadol; mentioned above; Other Names: Tramadex; Drug: Morphine; mentioned above; Drug: Tramal; mentioned above; Drug: Dipyrone; mentioned above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pain score 48 hours following surgery: visual numerical scale (VNS)	Using : visual numerical scale (VNS)	48 hours

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Study Chair: Michal Kovo, MD, Wolfson Medical Center

Publications and helpful links

General Publications

• Dafna L, Herman HG, Ben-Zvi M, Bustan M, Sasson L, Bar J, Kovo M. Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 May;1(2):112-118. doi: 10.1016/j.ajogmf.2019.04.002. Epub 2019 Apr 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): August 31, 2018

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Ibuprofen; Tramadol; Dipyrone
• Other Study ID Numbers: 0022-17-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No