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To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02440399
Enrollment
200
Registered
2015-05-12
Start date
2015-07-31
Completion date
2017-05-31
Last updated
2017-05-09

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

Conditions

Post Cesarean Pain Management

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.

Detailed description

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. Oral pain relievers' administration in fix protocol without need for patient demand 2. Spinal morphine given during the spinal anesthesia in the cesarean section

Interventions

DRUGTramadol hydrochloride

Please see arm description

DRUGMorphine

Please see arm description

DRUGParacetamol
DRUGDiclofenac
DRUGTAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)

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 No maximum
Healthy volunteers
No

Inclusion criteria

* women that underwent cesarean section with sinal anesthesia

Exclusion criteria

* Women who suffer from chronic pain * Women using chronic pain medications * Women with allergy to any drug used in the study * Women underwent general anesthesia during the surgery * Women who suffer from sleep apnea * Women who suffer from obesity (BMI\>40) * Women who suffer from severe nausea and vomiting after previous surgery * Women who received perioperative magnesium * Women who suffer from hypertension * Women who suffer from renal failure

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of pain managementduring 48 hours from surgeryPain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain

Secondary

MeasureTime frameDescription
The necessity of additional medications (rescue doses)During 48 hours after surgery
Adverse effect of the medications given in each protocol on the mother and neonatesduring 48 hours following surgery
Patient satisfaction48 hours after surgeryEach patient will fill in a satisfaction questioner which is given 48 hours after surgery
Total amount of pain medications required in each study groupduring 48 hours following surgery and after 7 days
The efficacy of pain management during 4 days past surgeryduring 4 days past surgeryPain sensation will be assessed using the VAS scale
To compare the amount of breastfeeding between 2 groupsFollowing the week after surgery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026