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Comparing Protocols for Analgesia Following Elective Cesarean Section

Comparing Protocols for Analgesia Following Elective Cesarean Section

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03622489
Enrollment
120
Registered
2018-08-09
Start date
2017-03-01
Completion date
2018-08-31
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Post-Cesarean Section

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.

Interventions

DRUGTramadol

mentioned above

DRUGAcetaminophen

mentioned above

DRUGIbuprofen 400 mg

mentioned above

mentioned above

DRUGMorphine

mentioned above

DRUGTramal

mentioned above

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Average pain score 48 hours following surgery: visual numerical scale (VNS)48 hoursUsing : visual numerical scale (VNS)

Countries

Israel

Contacts

Primary ContactLotem Dafna, MD
lotemdafne@yahoo.com+972524205415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026