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

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

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement
• Intervention / Treatment: Drug: Fentanyl

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 .

In the clinical ICU, patient-controlled intravenous analgesia (PCIA) has been used to improve postoperative pain management. Titrate analgesics according to demand. It typically provides better pain management and increases patient satisfaction when compared to "on-demand" opioid injections .

The settings programmed into the PCIA machine, such as the bolus dosage, lockout interval, dose restrictions, and background infusion, are included in the PCIA prescription. Each of these factors might have an impact on the safety and efficacy of PCIA.

A new fentanyl-based PCIA therapy has been developed to overcome constraints associated with PCIA provided by IV, such as programming mistakes, mobility limits, and the danger of needle stick injuries.

Prommer and colleagues demonstrated that a fentanyl dosage delivered through PCIA resulted in a mean C max of 1.954 ug/L and a mean absorption of 39.5 ug fentanyl per 10-minute dose delivery time .

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt
      • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients with total fracture of Hip bones

Exclusion Criteria:

1. History of mental or neurological complaints,
2. Opioid and local anaesthetic allergies,
3. Opioid tolerance,
4. Smoking history,
5. local infection,
6. cemented total hip arthroplasty (THA), revision THA,
7. preoperative DVT,
8. renal failure,
9. bleeding tendency due to anticoagulant therapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fentanyl infusion Group; 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; 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; Other Names: hyperbaric bupivacaine
Experimental: NO fentanyl infusion Group; All patients underwent combined spinal and epidural anesthesia (CSEA) with 2 ml of 0.5 % hyperbaric bupivacaine only	Drug: Fentanyl; 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; Other Names: hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Collaborators: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: NIRVANA (Alias Study Number)

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: No
• Studies a U.S. FDA-regulated device product: No