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

Post Cesarean Pain Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440399
• Other study ID #: 0028-15
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: May 8, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Cesarean Pain Management

Intervention

Drug:
• Tramadol hydrochloride
Please see arm description
• Morphine
Please see arm description
• Paracetamol

• Diclofenac

• TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)

Locations

Country	Name	City	State
Israel	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 NRS scale (numeric rating scale) for measurement of acute pain	during 48 hours from surgery
Secondary	Patient satisfaction	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery	48 hours after surgery
Secondary	The necessity of additional medications (rescue doses)		During 48 hours after surgery
Secondary	Adverse effect of the medications given in each protocol on the mother and neonates		during 48 hours following surgery
Secondary	To compare the amount of breastfeeding between 2 groups		Following the week after surgery
Secondary	Total amount of pain medications required in each study group		during 48 hours following surgery and after 7 days
Secondary	The efficacy of pain management during 4 days past surgery	Pain sensation will be assessed using the VAS scale	during 4 days past surgery