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

Cesarean Section Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764048
• Other study ID #: 0120-12-EMC
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: January 7, 2016
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: department of obstetric and gynecology, HaEmek Medical Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section
• Pain Management

Intervention

Drug:
• Fix protocol
Please see arm description
• medications following demand protocol
Please see arm description

Locations

Country	Name	City	State
Israel	Departement of obstetric and gynecology, HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of pain management	Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain	during 48 hours from surgery	No
Secondary	adverse effect of the medications given in each protocol		during 48 hours following surgery	Yes
Secondary	to compare the amount of breastfeeding between 2 groups		following the week after surgery	No
Secondary	The number of times that pain medications were given in each study group		during 48 hours following surgery	No
Secondary	The necessity of additional medications (rescue doses)		During 48 hours after surgery	No
Secondary	Patient satisfaction	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery	48 hours after surgery	No