Patient Control Epidural Versus Conventional Epidural.

December 26, 2024 updated by: Uruba Shamshad, Liaquat National Hospital & Medical College

Patient Control Epidural Versus Conventional Epidural After Total Hip Replacement

As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.

We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Liaquat National Hospital and Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient population will be from liaquat national hospital.

Description

Inclusion Criteria:

Age >18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 >95% Informed consent for participation.

Exclusion Criteria:

A history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).

Indication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity to study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PCEA group
Epidural catheter is inserted and patient is given a remote to control the amount of drug given through patient control epidural pump.
Non-PCEA group
Epidural catheter is inserted and the amount of drug set will be delivered via infusion pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue score
Time Frame: 24 hours

Patient satisfaction will be assessed after 2hours, 12hours and 24hours after surgery according to patient's pain intensity.

Score will be from 1-10, 10 means maximum satisfaction and 1 means minimal satisfaction.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat National Hospital & Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Estimated)

January 25, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • App # 0881- 2023- LNH - ERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Considering patient's status of understanding i will decide it later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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