The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Morphine; Drug: Morphine plus Nalbuphine

• Registration Number: NCT02716129
• Lead Sponsor: Abdelrady S Ibrahim, MD

Brief Summary

The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.

Detailed Description

The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-23
• Study Start: 2016-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-24
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Female patients
• age between 16 to 40 years
• ASA physical status I - II

Exclusion Criteria

• Infection at the site of injection.
• Coagulopathy or other bleeding diathesis.
• Preexisting neurologic deficits.
• History of hypersensitivity to any of the given the drugs.
• Inability to communicate with the investigator and the hospital staff.
• History of chronic opioid us

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Morphine	Morphine group
Group 2	Morphine plus Nalbuphine	Morphine plus Nalbuphine group

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours	Visual Analogue Score

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative itching	24 hours	Visual Analogue Score
number of participants with incidence of postoperative nausea	24 hours	Patients number
number of participants with incidence of postoperative vomiting	24 hours	Patients number
number of participants with incidence of postoperative postdural puncture headache	24 hours	Patients number
number of participants with incidence of postoperative respiratory depression	24 hours	Patients number

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt