Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl

NCT05429567 | Completed Phase 1 DMC

• 1 other identifier: NIRVANA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To enhance post-operative pain management, patient-controlled intravenous analgesia (PCIA) has been employed. The fentanyl background PCIA therapy was created to solve the limitations of IV-based PCIA, such as programming errors, mobility limitations, and the risk of needle stick injuries. The goal of this trial was to observe how fentanyl patient-controlled intravenous analgesia pump (PCIA) and background infusion is worked in patients with post-total hip replacement analgesia.

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Fentanyl Background

  Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl Background Infusion for Total Hip Replacement

  from 0 hours to 36 hours after the completion of the operation

Study Arms (2)

fentanyl infusion Group

EXPERIMENTAL

According to the body weight, 2 ug/kg fentanyl was diluted to 100 ml with normal saline. with rate of 2 mL/h infusions, 10 min lockout time and Initial PCIA analgesia regimen consisting of a 0.5 mL bolus was commenced to be given to the patients postoperative with evaluation the pain

Drug: Fentanyl

NO fentanyl infusion Group

EXPERIMENTAL

All patients underwent combined spinal and epidural anesthesia (CSEA) with 2 ml of 0.5 % hyperbaric bupivacaine only

Drug: Fentanyl

Interventions

Fentanyl DRUG

All patients underwent combined spinal and epidural anesthesia (CSEA) with 2 ml of 0.5 % hyperbaric bupivacaine and 25 ug fentanyl administered using a 27-gauge Whitacre spinal needle and an 18-gauge Tuohy needle in the epidural space. The epidural space was identified utilizing the loss of resistance approach

Also known as: hyperbaric bupivacaine

NO fentanyl infusion Group; fentanyl infusion Group

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Patients with total fracture of Hip bones

You may not qualify if:

• History of mental or neurological complaints,
• Opioid and local anaesthetic allergies,
• Opioid tolerance,
• Smoking history,
• local infection,
• cemented total hip arthroplasty (THA), revision THA,
• preoperative DVT,
• renal failure,
• bleeding tendency due to anticoagulant therapy

Sponsors & Collaborators

• Egymedicalpedia: lead
• October 6 University: collaborator

Study Sites (1)

October 6 University

Giza, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nirvana Elshalakany, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 23, 2022
• Study Start: March 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 28, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

EG (1)