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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01764048
First received: January 2, 2013
Last updated: January 7, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention
Pain Management
Cesarean Section
Drug: Fix protocol
Drug: medications following demand protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Each patient will fill in a satisfaction questioner which is given 48 hours after surgery

  • the efficacy of pain management [ Time Frame: during 48 hours from surgery ] [ Designated as safety issue: No ]
    Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain

  • The necessity of additional medications (rescue doses) [ Time Frame: During 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse effect of the medications given in each protocol [ Time Frame: during 48 hours following surgery ] [ Designated as safety issue: Yes ]
  • to compare the amount of breastfeeding between 2 groups [ Time Frame: following the week after surgery ] [ Designated as safety issue: No ]
  • Total amount of pain medications required in each study group [ Time Frame: during a week following surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fix protocol

During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):

At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams

After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).

After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.

Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.

The total amount of paracetamol is limited to 4 gr per day.

Drug: Fix protocol
Please see arm description
Experimental: medications following demand protocol
The same combinations will be given as in the fixed protocol however only after patient request
Drug: medications following demand protocol
Please see arm description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764048

Contacts
Contact: Zohar Nachum, MD 972-46495483
Contact: Enav Yefet, MD/PhD 972-46495483

Locations
Israel
Departement of obstetric and gynecology, HaEmek medical center Recruiting
Afula, Israel, 18101
Principal Investigator: Enav Yefet, MD/PhD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01764048     History of Changes
Other Study ID Numbers: 0120-12-EMC
Study First Received: January 2, 2013
Last Updated: January 7, 2013
Health Authority: Israel: department of obstetric and gynecology, HaEmek Medical Center

Keywords provided by HaEmek Medical Center, Israel:
pain management
cesarean section

ClinicalTrials.gov processed this record on September 16, 2014