Comparing Protocols for Analgesia Following Elective Cesarean Section
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 postoperative-pain
Started Mar 2017
Typical duration for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 5, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedAugust 9, 2018
June 1, 2018
1.5 years
August 5, 2018
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Average pain score 48 hours following surgery: visual numerical scale (VNS)
Using : visual numerical scale (VNS)
48 hours
Study Arms (3)
Tab ibuprofen + IV acetaminophen
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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.
Interventions
mentioned above
mentioned above
mentioned above
mentioned above
mentioned above
Eligibility Criteria
You may qualify if:
- Women undergoing elective cesarian section
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wolfson medical center
Holon, Israel
Related Publications (1)
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.
PMID: 33345816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michal Kovo, MD
Wolfson Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2018
First Posted
August 9, 2018
Study Start
March 1, 2017
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
August 9, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share