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

Abdelrady S Ibrahim, MD80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain

Interventions

MorphineDRUG

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.

Morphine plus NalbuphineDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Assiut university faculty of medicine

Asyut, Egypt

Outcomes

Primary Outcomes

Postoperative pain

Visual Analogue Score

Time frame: 24 hours

Secondary Outcomes

Incidence of postoperative itching

Visual Analogue Score

Time frame: 24 hours

number of participants with incidence of postoperative nausea

Patients number

Time frame: 24 hours

number of participants with incidence of postoperative vomiting

Patients number

Time frame: 24 hours

number of participants with incidence of postoperative postdural puncture headache

Patients number

Time frame: 24 hours

number of participants with incidence of postoperative respiratory depression

Patients number

Time frame: 24 hours

Data from ClinicalTrials.gov

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