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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716129
• Other study ID #: IRB0000871235
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2016
• Last updated: December 24, 2017
• Start date: July 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Visual Analogue Score	24 hours
Secondary	Incidence of postoperative itching	Visual Analogue Score	24 hours
Secondary	number of participants with incidence of postoperative nausea	Patients number	24 hours
Secondary	number of participants with incidence of postoperative vomiting	Patients number	24 hours
Secondary	number of participants with incidence of postoperative postdural puncture headache	Patients number	24 hours
Secondary	number of participants with incidence of postoperative respiratory depression	Patients number	24 hours