NCT02716129

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

Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Abdelrady S Ibrahim, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Morphine	38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
DRUG	Morphine plus Nalbuphine	39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-03-23
• Last updated: 2017-12-27

Locations

1 site across 1 country: Egypt