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To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01764048
Enrollment
214
Registered
2013-01-09
Start date
2012-11-30
Completion date
2014-06-30
Last updated
2016-01-08

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

Conditions

Cesarean Section, Pain Management

Keywords

pain management, cesarean section

Brief summary

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request). The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses). The protocols will be used for the first 48 hours following surgery.

Interventions

DRUGFix protocol

Please see arm description

DRUGmedications following demand protocol

Please see arm description

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* women that underwent cesarean section

Exclusion criteria

* Women suffering from chronic pain * Women using chronic pain medications * Allergy to any drug used in the study * Women underwent general anesthesia during the surgery * women with elevated liver enzymes

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of pain managementduring 48 hours from surgeryPain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain

Secondary

MeasureTime frameDescription
adverse effect of the medications given in each protocolduring 48 hours following surgery
to compare the amount of breastfeeding between 2 groupsfollowing the week after surgery
The number of times that pain medications were given in each study groupduring 48 hours following surgery
The necessity of additional medications (rescue doses)During 48 hours after surgery
Patient satisfaction48 hours after surgeryEach patient will fill in a satisfaction questioner which is given 48 hours after surgery

Countries

Israel

Outcome results

None listed

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