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

Abdelrady S Ibrahim, MD

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Morphine plus Nalbuphine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02716129

IRB0000871235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Morphine group

Treatment:

Drug: Morphine

Group 2

Active Comparator group

Description:

Morphine plus Nalbuphine group

Treatment:

Drug: Morphine plus Nalbuphine