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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Efficiency, Spinal Anesthesia, Block
- 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 group | Role | What 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.
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
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.
- First posted17 Jan 2024
- Study start15 Dec 2021
- Primary completion15 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EfficiencyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyyup Sabri Ozden, Suleyman Demirel University
- Investigators
- Eyyup Ozden, Principal investigator, Suleyman Demirel University
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 32231802Afolayan 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06209372
- Acronym / sponsor ID
- PENG / 281570
- Conditions
- Efficiency, Spinal Anesthesia, Block
- Keywords
- Fracture, Hip;, Block, Pericapsular Nerve Group;, Anesthesia, Spinal;, Success;, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 Jan 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PENG (P) | – | Procedure: Group PENGGroup 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. |
| Group Control (C) | – | Drug: Group CGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing hip fracture surgery
Key inclusion criteria (2 listed)
- Over 18 years old
- American Society of Anesthesiologists' (ASA) I-II-III
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group PENGPericapsular Nerve Group Block (PENG) | Procedure or surgery | Group PENG (P) |
| Group CTramadol infusion | Drug | Group Control (C) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Results publication: PubMed 32231802Acharya 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.
- Results publication: PubMed 29629009Afolayan 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Eyyup Ozden principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
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.