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

Sponsor

Abdelrady S Ibrahim, MD (Other)

Overall Status

Completed

CT.gov ID

NCT02716129

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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

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 :

Jul 1, 2016

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 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 Names: 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 Names: Infumorph and NALUFIN

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 Names:

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 Names:

Infumorph and NALUFIN

Outcome Measures

Primary Outcome Measures

Postoperative pain [24 hours]
Visual Analogue Score

Secondary Outcome Measures

Incidence of postoperative itching [24 hours]
Visual Analogue Score
number of participants with incidence of postoperative nausea [24 hours]
Patients number
number of participants with incidence of postoperative vomiting [24 hours]
Patients number
number of participants with incidence of postoperative postdural puncture headache [24 hours]
Patients number
number of participants with incidence of postoperative respiratory depression [24 hours]
Patients number

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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:

Mar 23, 2016

Last Update Posted:

Dec 27, 2017

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Morphine

Nalbuphine

Study Results

No Results Posted as of Dec 27, 2017