Clinical trial NCT02440399: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Cesarean Pain Management
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of pain management
timeFrame: during 48 hours from surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 48 hours after surgery
measure: The necessity of additional medications (rescue doses)
timeFrame: During 48 hours after surgery
measure: Adverse effect of the medications given in each protocol on the mother and neonates
timeFrame: during 48 hours following surgery
measure: To compare the amount of breastfeeding between 2 groups
timeFrame: Following the week after surgery
measure: Total amount of pain medications required in each study group
timeFrame: during 48 hours following surgery and after 7 days
measure: The efficacy of pain management during 4 days past surgery
timeFrame: during 4 days past surgery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
citation: Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31.