NCT06721000

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 3, 2024

Last Update Submit

December 26, 2024

Conditions

Post Operative Pain, AcuteSedation ScoreDegree of Motor BlockLength of Hospital StayAmount of Analgesic Used

Keywords

Patient control epidural analgesiaConventional epidural

Outcome Measures

Primary Outcomes (1)

  • Visual analogue score

    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

Study Arms (2)

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient population will be from liaquat national hospital.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat national hospital and medical college

Karachi, Sindh, Pakistan

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Uruba

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

November 10, 2023

Primary Completion

May 30, 2024

Study Completion

January 25, 2025

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations

PA(1)