Hip SurgeryNCT06672289
Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application
An observational study of Hip Surgery, run by TC Erciyes University.
Trial summary
Suprainguinal Fascia iliac compartment outlet and Pericapsular nerve reduction, which is a routinely successful method for postoperative analgesia in anesthesia practice; the aim is to investigate information regarding postoperative pain level, analgesic consumption, patient satisfaction and discharge time after arm… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Surgery
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 15 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yunus Emre VURAL Dr Dr. Yunus Emre VURAL, Research assistant contact
About this study
Official title: Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application in Patients Undergoing Hip Arthroscopy
Suprainguinal Fascia iliac compartment outlet and Pericapsular nerve reduction, which is a routinely successful method for postoperative analgesia in anesthesia practice; the aim is to investigate information regarding postoperative pain level, analgesic consumption, patient satisfaction and discharge time after arm arthroscopy.
Read the 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.
- Conditions
- Hip Surgery
- Keywords
- hip arthroscopy, PENG block, Suprainguinal Fascia Iliaca Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score
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
Measured: 2-3 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672289
- Sponsor's protocol ID
- 2024/162
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application in Patients Undergoing Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT06672289
- Acronym / sponsor ID
- 2024/162
- Conditions
- Hip Surgery
- Keywords
- hip arthroscopy, PENG block, Suprainguinal Fascia Iliaca Block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suprainguinal Fascia iliac compartment outlet and Pericapsular nerve reduction, which is a routinely successful method for postoperative analgesia in anesthesia practice; the aim is to investigate information regarding postoperative pain level, analgesic consumption, patient satisfaction and discharge time after arm arthroscopy.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy
Key inclusion criteria (7 listed)
- 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 opioid addiction
- Patients who have the ability to use the patient-controlled analgesia (PCA) device and perform VAS scoring
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hip Surgery
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yunus Emre VURAL Dr Dr. Yunus Emre VURAL, Research assistant contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Surgery, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recep AKSU MD Recep AKSU, MD, Professor (+90 5337461200, raksu@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (time frame: 2-3 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.