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Completed

NCT Number: NCT02716129

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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.

Other names: Infumorph

Morphine plus Nalbuphine

Drug

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.

Other names: Infumorph and NALUFIN

Primary outcomes

  1. Postoperative pain

    Time frame: 24 hours

    Visual Analogue Score

Secondary outcomes

  1. Incidence of postoperative itching

    Time frame: 24 hours

    Visual Analogue Score

  2. number of participants with incidence of postoperative nausea

    Time frame: 24 hours

    Patients number

  3. number of participants with incidence of postoperative vomiting

    Time frame: 24 hours

    Patients number

  4. number of participants with incidence of postoperative postdural puncture headache

    Time frame: 24 hours

    Patients number

  5. number of participants with incidence of postoperative respiratory depression

    Time frame: 24 hours

    Patients number

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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