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

• ClinicalTrials.gov Identifier: NCT02716129
• Recruitment Status: Completed
• First Posted: March 23, 2016
• Last Update Posted: December 27, 2017
• Sponsor: Abdelrady S Ibrahim, MD
• Information provided by (Responsible Party): Abdelrady S Ibrahim, MD, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Morphine; Drug: Morphine plus Nalbuphine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: October 2017
• Actual Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1; Morphine group	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.; Other Name: Infumorph
Active Comparator: Group 2; Morphine plus Nalbuphine group	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.; Other Name: Infumorph and NALUFIN

Outcome Measures

Primary Outcome Measures :

1. Postoperative pain [ Time Frame: 24 hours ]
   Visual Analogue Score

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Assiut university faculty of medicine

Assiut, Egypt

Sponsors and Collaborators

Abdelrady S Ibrahim, MD

Investigators

• Principal Investigator: Abdelrady S Ibrahim, MD; Assistant professor of anesthesia and intensive care

More Information

Publications:

Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5.

• Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and ICU, Assiut University
• ClinicalTrials.gov Identifier: NCT02716129
• Other Study ID Numbers: IRB0000871235
• First Posted: March 23, 2016
• Last Update Posted: December 27, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Morphine; Nalbuphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents