- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209372
The Efficiency of Preoperative Pericapsular Nerve Group Block Applied With Ultrasound and Success of Spinal Anesthesia (PENG)
The Efficiency of Preoperative Pericapsular Nerve Group Block Applied With Ultrasound in Patients With Hip Fracture and Its Effect on the Success of Spinal Anesthesia (PENG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted after obtaining approval from the Clinical Research Ethics Committee of Süleyman Demirel University (SDU) Faculty of Medicine (Decision no. 281570, dated 10.06.2022). Between December 2021 and June 2022, hip fracture surgery was performed on 100 patients 18 yr and older who were in the American Society of Anesthesiologists' (ASA) I-II-III risk group, using spinal anesthesia at the SDU Faculty of Medicine Hospital Operating Room. The patients' files were reviewed, including those who received the PENG block ın the PCU and those who did not.
Patients with a history of chronic pain, previous hip joint surgery, those who had an unsuccessful PENG block application, and those with missing data in their medical records were excluded from the study (Figure 1). After excluding patients who did not meet the study criteria, 60 patients, including 30 who received the PENG block and 30 who did not, were included in the study.
When the patients were brought to the PCU, they were informed about the procedure, and written consent was obtained after explanation. Standard ASA monitoring was performed after obtaining consent. Patients with full cooperation were informed about the numeric rating scale (NRS), and their pain scores were recorded on the pain follow-up form. If there were no contraindications, 1 g of paracetamol was administered to all patients. After the pain score was assessed in the PCU, a preemptive PENG block was applied, or 10 mg of tramadol IV push was administered, followed by 10 mg/hr infusion, depending on the patient's clinical condition. Group PENG (P) received the PENG block with 20 mL of 0.25% bupivacaine under ultrasound guidance at PCU. The linear USG probe for the PENG block was placed parallel to the imaginary line passing between the spina iliaca anterior inferior and the iliopubic eminence (IPE). The 80mm peripheral block needle was advanced with the in-plane technique, and the block was completed by injecting 20 mL of 0.25% bupivacaine. In Group Control (C), patients who did not prefer the block were given 10 mg of IV bolus tramadol, followed by 10 mg/hr infusion at PCU.
The NRS scores of all patients were recorded, and if the NRS score was >3, 10 mg of IV bolus tramadol was administered with a waiting time of 30 min before starting the surgical intervention. After 30 min of analgesic treatment, the patient was transported to the operating table.
If regional anesthesia was planned for patients, except for specific situations, unilateral hypobaric spinal anesthesia was applied in the standard lateral decubitus position. All patients were administered 1.5 mL of 0.5% bupivacaine (7.5 mg) + 1.5mL of distilled water + 0.25 mL of fentanyl (12.5 mcg) prepared with a 25 G - 90 mm cutting-edge disposable spinal needle. The number of attempts, the success of the dural puncture, and the time of skin incision were recorded on the anesthesia follow-up form. In addition, the level of spinal anesthesia was determined by the pinprick test at the 5th min.
The patients' demographic data, the surgical procedure and duration, the patient's postoperative discharge site, heart rate, mean arterial pressure (MAP), and peripheral saturation (SpO2) values measured during pre-analgesic application 30 min after, before spinal anesthesia, during skin incision, during the first hour of surgery, and postoperative discharge were recorded and evaluated from hospital information system data, anesthesia follow-up forms, surgical notes, perioperative pain monitoring forms, and discharge reports. Similarly, the spinal anesthesia duration (the time between the start of spinal anesthesia to skin incision), the number of spinal anesthesia attempts, the patient's position during the transfer from the bed to the operating table, the lateral decubitus position, skin incision, and NRS values at postoperative exit, and at the 2nd, 4th, 12th, and 24th hr postoperatively were recorded and evaluated. In the same manner, the total amount of tramadol administered during and after surgery, and postoperative complications (postoperative nausea and vomiting, hypotension, quadriceps muscle weakness, infection, hematoma, local anesthetic toxicity) were recorded and evaluated.
Statistical Analysis This article describes a statistical analysis performed on data using the Statistical Package for Social Science (SPSS) version 24. Qualitative data was presented as numbers and percentages, while quantitative data was presented as means and standard deviations (SD). The Kolmogorov-Smirnov and Shapiro-Wilk tests were used to check for normal distribution of continuous variables. The student's t-test was used to compare two independent groups of normally distributed variables, the Mann Whitney U test was used to compare two independent groups of variables that did not have a normal distribution, and the chi-square test was used to compare categorical data.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Centre
-
Isparta, Centre, Turkey, 32200
- Suleyman Demirel University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years old
- American Society of Anesthesiologists' (ASA) I-II-III
Exclusion Criteria:
- Patients with a history of chronic pain,
- Previous hip joint surgery,
- Unsuccessful PENG block or spinal anesthesia application,
- Missing data in their records
- History of bleeding diathesis
- Increased intracranial pressure
- Severe mitral and/or aortic stenosis
- Allergic to the medications used
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group PENG (P)
Group PENG (P) received the PENG block with 20 mL of 0.25% bupivacaine under ultrasound guidance at preoperative care unit (PCU).
The linear ultrasound probe for the PENG block was placed parallel to the imaginary line passing between the spina iliaca anterior inferior and the iliopubic eminence (IPE).
The 80mm peripheral block needle was advanced with the in-plane technique, and the block was completed by injecting 20 mL of 0.25% bupivacaine.
|
Pericapsular Nerve Group Block (PENG)
|
|
Group Control (C)
Group Control (C), patients who did not prefer the block were given 10 mg of IV bolus tramadol, followed by 10 mg/hr infusion at preoperative care unit (PCU).
|
Tramadol infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain score after applying Pericapsular Nerve Group Block (PENG)
Time Frame: 30 minutes after applying PENG block
|
In line with the literature, we determined that the NRS value significantly decreased during positioning for spinal anesthesia in the group where the PENG block was applied.
|
30 minutes after applying PENG block
|
|
Pericapsular Nerve Group Block (PENG) block facilitates the success of spinal anesthesia
Time Frame: 30 minutes after applying PENG block
|
Effective pain control facilitates the success of spinal anesthesia by making positioning and application easier is supported by our study.
|
30 minutes after applying PENG block
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eyyup Ozden, Suleyman Demirel University
Publications and helpful links
General Publications
- Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. eCollection 2020.
- Afolayan JM, Areo PO, Adegun PT, Ogundipe KO, Filani AB. Comparison of ease of induction of spinal anaesthesia in sitting with legs parallel on the table versus traditional sitting position. Pan Afr Med J. 2017 Nov 13;28:223. doi: 10.11604/pamj.2017.28.223.6992. eCollection 2017.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 281570
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
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.
Clinical Trials on Spinal Anesthesia
-
Samsung Medical CenterCompletedSpinal Anesthesia | Success or Failure of Spinal AnesthesiaKorea, Republic of
-
University of Alabama at BirminghamCompleted
-
Shaheed Mohtarma Benazir Bhutto Institue of TraumaRecruitingSpinal Anesthesia Induced Hypotension | Geriatric Population | Spinal Anesthesia in Elderly PatientsPakistan
-
Universidade do Vale do SapucaiCompletedAnesthesia, Epidural | Anesthesia, Spinal | AntisepsisBrazil
-
San Salvatore Hospital of L'AquilaCompletedAnesthesia, Local | Anesthesia; Functional | Spinal CordItaly
-
Tanta UniversityCompletedSpinal Anesthesia Evaluation | Analgesic | Intrathecal AnesthesiaEgypt
-
Antalya Training and Research HospitalCompletedAnesthesia, General | Anesthesia, Spinal | Umbilical CordTurkey
-
University Tunis El ManarRecruitingSpinal AnesthesiaTunisia
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Tongji HospitalCompleted
Clinical Trials on Group PENG
-
Ospedale Edoardo BassiniRecruitingRegional Anesthesia Morbidity | Arthropathy of Hip | Opioid Consumption | Hip Arthropathy | Complication of Anesthesia | Locoregional Anesthesia | Hospital Stay, Length of Stay in Hospital From Time of Surgery Till DischargeItaly
-
Benha UniversityNot yet recruitingPain, Postoperative
-
Antalya Training and Research HospitalRecruiting
-
Ain Shams UniversityCompleted
-
Ain Shams UniversityCompletedHip Hemiarthroplasty | Pericapsular Nerve Group Block | Lateral Femoral Cutaneous Nerve Block | Supra-inguinal Fascia Iliaca BlockEgypt
-
Zagazig UniversityCompletedPediatric Postoperative PainEgypt
-
Kirsehir Ahi Evran UniversitesiNot yet recruitingPostoperative Pain | Total Hip Arthroplasty (THA)
-
Ain Shams UniversityRecruitingShoulder Arthroscopy | Interscalene Brachial Plexus Block | Pericapsular Nerve BlockEgypt
-
Fatih Sultan Mehmet Training and Research HospitalCompletedPostoperative Pain | Hip Fractures | Postoperative Delirium (POD) | Hip ArthroplastyTurkey (Türkiye)
-
Ilker ItalAbant Izzet Baysal UniversityRecruitingPostoperative Pain | Hip FracturesTurkey