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 Overview
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Brief Summary
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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
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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: Oral pain relievers' administration in fix protocol without need for patient demand Spinal morphine given during the spinal anesthesia in the cesarean section

Official Title
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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

Conditions
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Post Cesarean Pain Management

Intervention / Treatment
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* Drug: Tramadol hydrochloride
* Drug: Morphine
* Drug: Paracetamol
* Drug: Diclofenac
* Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fix protocol - Oral treatment<br>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: Tramadol hydrochloride<br>* Please see arm description<br>Drug: Paracetamol<br> <br> Drug: Diclofenac<br> <br> Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)<br> <br> |
| Experimental: Spinal morphine<br>The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section | Drug: Morphine<br>* Please see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Each patient will fill in a satisfaction questioner which is given 48 hours after surgery | 48 hours after surgery | 
| The necessity of additional medications (rescue doses) |  | During 48 hours after surgery | 
| Adverse effect of the medications given in each protocol on the mother and neonates |  | during 48 hours following surgery | 
| To compare the amount of breastfeeding between 2 groups |  | Following the week after surgery | 
| Total amount of pain medications required in each study group |  | during 48 hours following surgery and after 7 days | 
| The efficacy of pain management during 4 days past surgery | Pain sensation will be assessed using the VAS scale | during 4 days past surgery |