- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06672289
Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application
Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application in Patients Undergoing Hip Arthroscopy
Study Overview
Status
Conditions
Detailed Description
Patients will be monitored with routine monitoring under operating room conditions. After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia. After the site is cleaned, a pericapsular nerve block (PENG) or suprainguinal fascia iliac block (SFIB) will be performed under USG guidance. After the procedure, the patient will be transferred to the surgical team for positioning. Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery.
After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity. Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded. Patient-controlled Analgesia (PCA) will be used for postoperative analgesia for all patients, as is routinely done, and total analgesic consumption will be evaluated. Hemodynamic data, VAS pain scores, and observed hemodynamic data of the patients were examined at 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours in the postoperative period. Side effects will be recorded. The evaluation of the pain occurring when the hip is immobilized (VASd) and when it is moved (VASh) will be made by the anesthesiologist with VAS.
Patients' 24-hour postoperative satisfaction will be evaluated. Within the scope of the study, patients' gender, age, height, weight, ASA risk scores and operation times will be recorded.
In the statistical evaluation of the study; Analgesic consumption during the procedure, VAS scores, and analgesic consumption and patient satisfaction in the postoperative period will be evaluated and compared between groups.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Recep AKSU MD Recep AKSU, MD, Professor
- Phone Number: +90 5337461200
- Email: raksu@erciyes.edu.tr
Study Contact Backup
- Name: Yunus Emre VURAL Dr Dr. Yunus Emre VURAL, Research assistant
- Phone Number: +90 5063515914
- Email: dryemrevural@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy
- ASA I-II group patients
Patients without allergies
- Patients without psychiatric disorders
- Patients without opioid addiction
- Patients who have the ability to use the patient-controlled analgesia (PCA) device and perform VAS scoring
- Patients with no contraindications for peripheral blocks
Exclusion Criteria:
- Patients who do not want to participate in the study
- Patients with uncontrolled hypertension
- Patients with chronic pain or receiving pain treatment,
- Significant Cardiac Disorder (Coronary Artery Disease, Arrhythmia, Electrocardiography Anomaly, Heart Failure, etc.)
- Patients with Diabetes Mellitus
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Pericapsular Nerve Block (PENG)
Patients will be monitored with routine monitoring under operating room conditions.
After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia.
After the site is cleaned, pericapsular nerve block (PENG) will be applied under USG guidance.
After the procedure, the patient will be transferred to the surgical team for positioning.
Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery.
After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity.
Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded.
|
|
Suprainguinal Fascia Iliaca Block (SFIB)
Patients will be monitored with routine monitoring under operating room conditions.
After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia.
After the site is cleaned, suprainguinal fascia iliaca block (SFIB) will be applied under USG guidance.
After the procedure, the patient will be transferred to the surgical team for positioning.
Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery.
After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity.
Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Score
Time Frame: 2-3 hours after surgery
|
A Visual Analogue Scale (VAS) is one of the pain rating scales.
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest the VAS score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain
|
2-3 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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