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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05642975
Other study ID # 11.2022.546
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date May 1, 2023

Study information

Verified date October 2023
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation. Despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures. The primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients over 18 years old, undergoing hip fracture surgery Exclusion Criteria: - Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.

Study Design


Intervention

Procedure:
Regional Block Comparison
Comparing postoperative pain and opioid consumption in groups

Locations

Country Name City State
Turkey Marmara University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain Scores Comparing pain scores with Numeric Rating Scale (NRS) 48 hours
Primary Opioid Consumption Comparing opioid consumption via Patient Controlled Analgesia (PCA) device 48 hours
Secondary Patient Satisfaction patient satisfaction score: 0: unsatisfied 5: fully satisfied 48 hours
Secondary Complications Related to Pain Management complications such as hypothension, nausea, vomiting, itching 48 hours
Secondary Time of Mobilisation time frame between the surgery to first mobilization (walking) 7 days
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