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Clinical Trials/NCT05429567
NCT05429567CompletedPhase 1

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

Egymedicalpedia1 site in 1 country70 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Fentanyl Background

Study Overview

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.

Detailed Description

Significant efforts to enhance the treatment of postoperative pain have resulted in the formulation and implementation of pain management guidelines, as well as the introduction of acute pain services in several hospitals during the last two decades.

Recent research, however, suggests that postoperative pain is still poorly controlled .

Hip replacement procedures are prevalent among the elderly, and they are significantly more painful .

The patient may suffer greatly as a result of the pain, which can also affect physiological functioning caused by hormonal changes caused by sympathetic nervous system activation .

Anaesthesiologists and patients alike are concerned about pain management following major surgery. It should also be mentioned that every pain management medication has certain side effects, especially when an opioid is utilized .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
— to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with total fracture of Hip bones

Exclusion Criteria

  • 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

Arms & Interventions

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

Intervention: Fentanyl (Drug)

NO fentanyl infusion Group

Experimental

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

Intervention: Fentanyl (Drug)

Outcomes

Primary Outcomes

Fentanyl Background

Time Frame: from 0 hours to 36 hours after the completion of the operation

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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