Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine As a Postoperative Analgesia in Lower Limb Surgeries

NCT06720506 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: fentanyl Vs nalbuphine LL surg
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain management has been a major challenge and there has been great interest about it ., there have been persistent efforts to bring out the best possible analgesic technique with the least side effects. The popularity of lower limb surgeries owing to its higher incidence, orthopedic and vascular surgerise. Inadequate postoperative pain relief is associated with undesirable side effects resulting in chronic persistent pain, delayed recovery Concern about opioid has powerful effect in relief post operative pain. the aim of this study is to Compare between fentanyl intrathecal and nalbuphine IV as a postoperative analgesia in lower limb surgeries

Conditions

Lower Limb Surgery

Keywords

fentanyl; nalbuphine

Outcome Measures

Primary Outcomes (1)

• first request of rescue analgesia

  Duration of analgesia until first analgesic request

  24 hours

Study Arms (2)

group F

EXPERIMENTAL

patients will received intrathecal with dose 10-20ug

Drug: fentanyl

group N

EXPERIMENTAL

Nalbuphine will given IV as shot in. Dose 1mg /kg

Drug: Nalbuphine

Interventions

fentanyl DRUG

Fentanyl will be given intrathecal with dose 10-20ug

group F

Nalbuphine DRUG

Nalbuphine will given IV as shot in Dose 1mg /kg

group N

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male and female pt between 18 and 600 year
• pt with lower limb surgeries with no. Indication for general anathesia
• patient with no contraindication for spinal anatthesia

You may not qualify if:

• pt who refuses
• pt with hypersensivity to any drug
• pt addicts opiods
• chronic use of opiod
• Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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. doi: 10.1097/00000539-200009000-00019.

  PMID: 10960384 BACKGROUND

• Pick CG, Paul D, Pasternak GW. Nalbuphine, a mixed kappa 1 and kappa 3 analgesic in mice. J Pharmacol Exp Ther. 1992 Sep;262(3):1044-50.

  PMID: 1326621 BACKGROUND

MeSH Terms

Interventions

Fentanyl; Nalbuphine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Ahmed Khaled Helmy Abdelbasser, resident doctor

CONTACT

+2 01146445677; Ahmed.16266101@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anathesia and icu department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12