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EfficiencyPENGNCT06209372

The Efficiency of Preoperative Pericapsular Nerve Group Block Applied With Ultrasound and Success of Spinal Anesthesia

An observational study of Efficiency and Spinal Anesthesia, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We aimed to investigate the effectiveness of the pericapsular nerve group (PENG) block applied with preoperative ultrasonography (USG) in patients who were operated on under spinal anesthesia due to hip fracture and whether it influences spinal anesthesia success. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Efficiency, Spinal Anesthesia, Block
What is being tested?
Group PENG and Group C
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2021to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing hip fracture surgery

Who may be able to join

  • Over 18 years old
  • American Society of Anesthesiologists' (ASA) I-II-III

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Suleyman Demirel University Hospital

    Isparta, Centre, 32200

Other trials in Turkey (Türkiye)

About this study

Official title: 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)

We aimed to investigate the effectiveness of the pericapsular nerve group (PENG) block applied with preoperative ultrasonography (USG) in patients who were operated on under spinal anesthesia due to hip fracture and whether it influences spinal anesthesia success. The files of 100 patients were reviewed observationally, and 60 patients were included in the study. The patients were divided into two groups: Group P (n = 30) comprising patients who underwent PENG block under USG guidance before the start of surgery and the control group (Group C; n = 30) of patients in whom tramadol infusion was started. From the files of the patients, the transition from the bed to the operating table, lateral decubitus position, skin incision, postoperative exit, postoperative 2nd, 4th, 12th, and 24th hour numeric rating scale (NRS) values, spinal anesthesia duration and number of attempts, and perioperative total tramadol consumption were recorded. During the transfer from the patient bed to the operating table and during the lateral decubitus position, postoperative exit and postoperative 2nd, 4th, 8th, 12th, and 24th hour NRS values were found to be significantly lower in Group P. In addition, lower spinal anesthesia time, lower number of spinal anesthesia attempts, and lower perioperative total tramadol consumption were detected in Group P. We found that PENG block applied preoperatively to patients with spinal anesthesia decreased the perioperative pain score, increased the success of spinal anesthesia by facilitating positioning for spinal anesthesia, and decreased the need for postoperative opioids.

Read the 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.

Being tested
Group PENG, Group C
Keywords
Fracture, Hip;, Block, Pericapsular Nerve Group;, Anesthesia, Spinal;, Success;, Ultrasound
Medical subject headings
Bites and Stings, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group PENGProcedure or surgery

    Pericapsular Nerve Group Block (PENG)

  • Group CDrug

    Tramadol infusion

Study groups in NCT06209372
Study groupRoleWhat they receive
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.
Receives: Procedure: Group 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).
Receives: Drug: Group C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain score after applying Pericapsular Nerve Group Block (PENG)

    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.

    Measured: 30 minutes after applying PENG block

  2. Pericapsular Nerve Group Block (PENG) block facilitates the success of spinal anesthesia

    Effective pain control facilitates the success of spinal anesthesia by making positioning and application easier is supported by our study.

    Measured: 30 minutes after applying PENG block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start15 Dec 2021
  3. Primary completion15 Apr 2022
  4. Study completion1 Jun 2022

Resources

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
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06209372
Sponsor's protocol ID
281570
Acronym
PENG
Status last verified
Apr 2024
First submitted
5 Oct 2023
Last updated
26 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 32231802
  • 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.

    PubMed 29629009

Questions about this trial

What is this clinical trial studying?

An observational study of Efficiency and Spinal Anesthesia, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain score after applying Pericapsular Nerve Group Block (PENG) (time frame: 30 minutes after applying PENG block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06209372, which also lists 2 linked publications.

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 26 Apr 2024.

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