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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Surgery
• Intervention / Treatment: Drug: fentanyl; Drug: Nalbuphine

Detailed Description

Fentanyl, a potent lipid-soluble opioid which was first synthesized more than 40years ago, is still the most popular opioid used as post operative analgesia t. Fentanyl given intrathecally use in many acute and chronic pain conditions. inspite of its side effects fentanyl remains the mainstay of anesthesiologists in post operative period analgesia.

Anesthetic methods of Lower limb surgery such as orthopedic and vascular surgeries, for example in the use of local infiltration, spinal anesthesia, caudal anesthesia, or general anesthesia Among them, spinal anesthesia is commonly used for lower limb surgery which does not need a sophisticated machine and which has been performed for years before anesthetic equipment such as mechanical ventilators and monitoring devices was produced. The development of new local anesthetic agents, the use of opioids, and an interest in acute and chronic pain management have universalized spinal anesthesia. Immediate pain is very severe in lowerlimb surgery and difficul to control. Moreover, due to the short hospitalization period, there is a limit in the application of patient-controlled analgesia that permits patients to treat pain by directly activating doses of opoids .

Nalbuphine...

Nalbuphine is an agonist-antagonist opioid and provides prolonged duration of analgesia with

fewer side effects of fentanyl such as pruritus, nausea, and vomiting.

Nalbuphine has a powerful effect in decreasing postoperative pain nNalbuphine IS asynthetic agonistant agonist opioid, demonstrated to attenuate mu-opioid receptor-related adverse events such as pruritis, nausea/emesis, constipation respiratory depression, undesirable sedation, and the development of toler ance and dependence. With several clinical reports, nalbuphine has been recognized as a safe and highly efficacious opioid analgesic that possesses remarkably low narcotic abuse liability. As a result, nalbuphine provides an alternative choice to replace strong opioids for the clinical practice of post- operative pain managemen

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Khaled Helmy Abdelbasser, resident doctor; Phone Number: +2 01146445677; Email: Ahmed.16266101@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group F; patients will received intrathecal with dose 10-20ug	Drug: fentanyl; Fentanyl will be given intrathecal with dose 10-20ug
Experimental: group N; Nalbuphine will given IV as shot in. Dose 1mg /kg	Drug: Nalbuphine; Nalbuphine will given IV as shot in Dose 1mg /kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first request of rescue analgesia	Duration of analgesia until first analgesic request	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: fentanyl; nalbuphine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl; Nalbuphine
• Other Study ID Numbers: fentanyl Vs nalbuphine LL surg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes