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Comparing Protocols for Analgesia Following Elective Cesarean Section

Primary Purpose

Postoperative Pain, Post-Cesarean Section

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Acetaminophen
Ibuprofen 400 mg
Dipyrone
Tramadol
Morphine
Tramal
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Wolfson medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tab ibuprofen + IV acetaminophen

Tab Ibuprofen + Tab acetaminophen

"On demand" analgesia

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2018
Last Updated
August 8, 2018
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03622489
Brief Title
Comparing Protocols for Analgesia Following Elective Cesarean Section
Official Title
Comparing Protocols for Analgesia Following Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia: Scheduled doses of IV acetaminophen + PO Ibuprofen Scheduled doses of PO acetaminophen + PO Ibuprofen "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: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Post-Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tab ibuprofen + IV acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Tab Ibuprofen + Tab acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
"On demand" analgesia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
mentioned above
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
mentioned above
Intervention Type
Drug
Intervention Name(s)
Dipyrone
Intervention Description
mentioned above
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Tramadex
Intervention Description
mentioned above
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
mentioned above
Intervention Type
Drug
Intervention Name(s)
Tramal
Intervention Description
mentioned above
Primary Outcome Measure Information:
Title
Average pain score 48 hours following surgery: visual numerical scale (VNS)
Description
Using : visual numerical scale (VNS)
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lotem Dafna, MD
Phone
+972524205415
Email
lotemdafne@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Kovo, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Wolfson medical center
City
Holon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinat Hirsh
Phone
+97235028346
Email
rinath@wmc.org.il
First Name & Middle Initial & Last Name & Degree
Lotem Dafna, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33345816
Citation
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.
Results Reference
derived

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Comparing Protocols for Analgesia Following Elective Cesarean Section

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