- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07295184
Effect of Rebound Pain on Postoperative Intensive Care Delirium in Patients Undergoing Hip Surgery With Peripheral Nerve Block
Effect of Rebound Pain on Postoperative Intensive Care Delirium in Patients Undergoing Hip Surgery With Peripheral Nerve Block: A Prospective Observational Study
Postoperative delirium is a significant and commonly encountered complication in patients undergoing hip surgery, particularly among the elderly. Postoperative delirium is associated with serious consequences, including prolonged intensive care unit stay, increased complication rates, higher mortality risk, and rising healthcare costs.
The incidence of Postoperative delirium after hip fracture surgery has been reported to range between 13% and 55.9%, indicating a substantial clinical burden.
Effective postoperative pain control is critical not only for maintaining quality of life but also for preserving cognitive well-being. In this context, peripheral nerve blocks are frequently used for pain management following hip surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative delirium is a significant and commonly encountered complication in patients undergoing hip surgery, particularly among the elderly. Postoperative delirium is associated with serious consequences, including prolonged intensive care unit stay, increased complication rates, higher mortality risk, and rising healthcare costs.
The incidence of Postoperative delirium after hip fracture surgery has been reported to range between 13% and 55.9%, indicating a substantial clinical burden.
Effective postoperative pain control is critical not only for maintaining quality of life but also for preserving cognitive well-being. In this context, peripheral nerve blocks are frequently used for pain management following hip surgery.
In recent years, the Pericapsular Nerve Group block and the supra-inguinal fascia iliaca block have gained attention as regional anesthesia techniques that provide effective analgesia by targeting the nerve branches innervating the anterior capsule of the hip joint.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hasan SENAY, M.D.
- Phone Number: 05055078822
- Email: hasansenay@msn.com
Study Locations
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Karatay
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Konya, Karatay, Turkey (Türkiye), 42100
- Recruiting
- Konya City Hospital
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Contact:
- hasan şenay, MD
- Phone Number: +905055078822
- Email: drhasansenay@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
We conducted a pilot study on 20 patients using the 'goodness-of-fit tests: contingency tables' test with G Power software. In our study, the incidence of rebound pain was 40%, and postoperative delirium developed in 50% of patients with rebound pain, compared to 8.3% in patients without rebound pain.
Based on these data, an effect size of 0.356 was found, and an analysis was conducted using α=0.05, 90% power.
The sample size was calculated as 83 patients. Considering the dropout rate, a total of 90 patients (36 patients with rebound pain and 54 patients without rebound pain) were calculated to be included in the study.
Description
Inclusion Criteria:
- Patients aged 18-80
- ASA I-III risk groups
- Undergoing elective hip surgery
Exclusion Criteria:
- Preoperative history of delirium, dementia, or major neurological disease
- Present cognitive impairment or severe hearing or visual impairment that could affect pain assessment
- Development of mechanical ventilation requirement in the intensive care unit; Need for bilateral hip surgery
- Failure to provide meaningful analgesia after block application due to surgical pain outside the scope of the block
- Patient's inability to complete the pain diary during postoperative follow-up;
- Urgent hip surgery
- Voluntary failure to give consent or request to withdraw from the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of delirium
Time Frame: 72 hours
|
The incidence of delirium will be evaluated in the first 72 hours postoperatively in the intensive care unit.
|
72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Rebound pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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