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

NCT01764048 | Completed

• 1 other identifier: 0120-12-EMC
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Cesarean Section

Keywords

pain management; cesarean section

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• adverse effect of the medications given in each protocol

  during 48 hours following surgery

• to compare the amount of breastfeeding between 2 groups

  following the week after surgery

• The number of times that pain medications were given in each study group

  during 48 hours following surgery

• The necessity of additional medications (rescue doses)

  During 48 hours after surgery

• Patient satisfaction

  48 hours after surgery

Study Arms (2)

Fix protocol

EXPERIMENTAL

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

medications following demand protocol

EXPERIMENTAL

The same combinations will be given as in the fixed protocol however only after patient request

Drug: medications following demand protocol

Interventions

Fix protocol DRUG

Please see arm description

Fix protocol

medications following demand protocol DRUG

Please see arm description

medications following demand protocol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women that underwent cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Departement of obstetric and gynecology, HaEmek medical center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 9, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

IL (1)