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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

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ClinicalTrials.gov Identifier: NCT02440399
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
enav yefet, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Post Cesarean Pain Management Drug: Tramadol hydrochloride Drug: Morphine Drug: Paracetamol Drug: Diclofenac Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG) Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fix protocol - Oral treatment

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
Please see arm description

Drug: Paracetamol
Drug: Diclofenac
Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)
Experimental: Spinal morphine
The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section
Drug: Morphine
Please see arm description




Primary Outcome Measures :
  1. The efficacy of pain management [ Time Frame: during 48 hours from surgery ]
    Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 48 hours after surgery ]
    Each patient will fill in a satisfaction questioner which is given 48 hours after surgery

  2. The necessity of additional medications (rescue doses) [ Time Frame: During 48 hours after surgery ]
  3. Adverse effect of the medications given in each protocol on the mother and neonates [ Time Frame: during 48 hours following surgery ]
  4. To compare the amount of breastfeeding between 2 groups [ Time Frame: Following the week after surgery ]
  5. Total amount of pain medications required in each study group [ Time Frame: during 48 hours following surgery and after 7 days ]
  6. The efficacy of pain management during 4 days past surgery [ Time Frame: during 4 days past surgery ]
    Pain sensation will be assessed using the VAS scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440399


Locations
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Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel

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Responsible Party: enav yefet, MD/PhD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02440399     History of Changes
Other Study ID Numbers: 0028-15
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Morphine
Oxycodone
Tramadol
Acetaminophen, hydrocodone drug combination
Acetaminophen
Diclofenac
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action