Nalbuphine Versus Fentanyl As Additives To Bupivacaine In Spinal Anaesthesia For Internal FixationI Of Tibia

NCT03535792 | Completed

• 1 other identifier: 050108393
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Efficacy Of Nalbuphine Versus Fentanyl As Additives To Bupivacaine In Spinal Anaesthesia For Internal FixationI Of Tibia

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain Postoperative

  VAS 0-10

  24 hours

Study Arms (2)

Fentanyl/Hyperbaric Bupivacaine

ACTIVE COMPARATOR

Group F: Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1 ml fentanyl (50μg) and will have Tibial internal fixation.

Drug: Fentanyl/Hyperbaric bupivacaine

Nalbuphine/Hyerbaric Bupivacaine

ACTIVE COMPARATOR

Group N: Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1ml nalbuphine hydrochloride (1.6 mg); (nalufin 20 mg in 1 ml ampoule, Amoun Pharmaceutical Co. Cairo, Egypt) and will have Tibial internal fixation.

Drug: Nalbuphine/Hyperbaric bupivacaine

Interventions

Fentanyl/Hyperbaric bupivacaine DRUG

Intrathecal Fentanyl/Hyperbaric bupivacaine and Tibial internal fixation.

Also known as: Spinal Fentanyl/Hyperbaric bupivacaine

Fentanyl/Hyperbaric Bupivacaine

Nalbuphine/Hyperbaric bupivacaine DRUG

Intrathecal Nalbuphine/Hyperbaric bupivacaine and Tibial internal fixation.

Also known as: Spinal Nalbuphine/Hyperbaric bupivacaine

Nalbuphine/Hyerbaric Bupivacaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged 18-50 years
• American Society of Anesthesiologists (ASA) physical status I and II
• Scheduled for elective internal fixation of tibia, of expected duration less than 3 h, under subarachnoid block

You may not qualify if:

• Patients with significant co-existing conditions such as hepatic, renal and cardiovascular diseases.
• Patients with contraindications to regional anesthesia like local infection or bleeding disorders.
• Patients with allergy to opioids, long-term opioids use, and a history of chronic pain.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Nalbuphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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

Study Officials

• Mohammad Hazem I Ahmad Sabry, MB,ChB MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider and outcome assessor will not be informed with the medication used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: Group F: 25 Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1 ml fentanyl (50μg). Group N: 25 Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1ml nalbuphine hydrochloride (1.6 mg); (nalufin 20 mg in 1 ml ampoule, Amoun Pharmaceutical Co. Cairo, Egypt).

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 24, 2018
• Study Start: November 4, 2017
• Primary Completion: August 19, 2018
• Study Completion: August 20, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

EG (1)