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Hip FractureNCT06001996

Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture

An observational study of Hip Fracture, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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

The aim of this study is to apply pericapsular nerve group (PENG) block or fascia iliaca plan block using ultrasonography to patients who will undergo hip fracture surgery, while giving sitting position before spinal anaesthesia and to reduce postoperative pain complaints. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hip Fracture
What is being tested?
Pericapsular nerve group (PENG) block and Suprainguinal fascia iliaca plane block
How many people
67 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Oct 2023to 30 Jan 2024
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hip fracture

Who may be able to join

  • Patients between 18-70 years of age,
  • American Society of Anesthesiologists (ASA) Classification I-III,
  • scheduled for hip fracture surgery under spinal anaesthesia

Who cannot join

  • American Society of Anesthesiologists (ASA) Classification >III
  • known allergy to local anaesthetics
  • presence of preoperative chronic pain
  • presence of coagulopathy
  • those who are unable to give written consent

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    Diyarbakır, 21070

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Plane Block on Preoperative and Postoperative Analgesia Before Spinal Anaesthesia in Patients Undergoing Hip Fracture Surgery

The aim of this study is to apply pericapsular nerve group (PENG) block or fascia iliaca plan block using ultrasonography to patients who will undergo hip fracture surgery, while giving sitting position before spinal anaesthesia and to reduce postoperative pain complaints.

Thanks to these blocks, it is aimed to reduce pain complaints and the need for morphine-derived painkillers before and after surgery.

Read the detailed description

Group 1:Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the superior pubic ramus and local anaesthetic solution is injected.

  • Each patient will receive 15 ml of 0.375% bupivacaine on the side of the broken hip only one time approximately 15-20 minutes before the operation.
  • After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied.
  • plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  • Postoperative evaluations of patients will be performed face to face.
  • Plane block applications will be applied only once in the preoperative period.
  • Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above Numerical Rating Scale (NRS) 4 despite this.
  • This study was followed up in the orthopaedic service
  • Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
  • The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.
  • Data on the observed parameters will be obtained from face-to-face questionnaires or anesthesia and nurse observation forms.

Group 2: Suprainguinal fascia iliaca plane block: The needle entering in plane from the caudal end of the ultrasound probe passes through the m. sartorius and into the musculus iliacus and fascia iliaca reaches. The fascia iliaca is passed with the needle and local anaesthetic solution is injected immediately under the fascia.

  • Each patient will receive 15 ml of 0.375% bupivacaine on the side of the broken hip only one time approximately 15-20 minutes before the operation.
  • After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied.
  • plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  • Postoperative evaluations of patients will be performed face to face.
  • Plane block applications will be applied only once in the preoperative period.
  • Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above Numerical Rating Scale (NRS) 4 despite this.
  • This study was followed up in the orthopaedic service.
  • Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
  • The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.
  • Data on the observed parameters will be obtained from face-to-face questionnaires or anesthesia and nurse observation forms.
  • Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.

SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.

Conditions
Hip Fracture
Being tested
Pericapsular nerve group (PENG) block, Suprainguinal fascia iliaca plane block
Medical subject headings
Hip Fractures

What participants receive

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

  • Pericapsular nerve group (PENG) blockProcedure or surgery

    Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the superior pubic ramus and local anaesthetic solution is injected.

  • Suprainguinal fascia iliaca plane blockProcedure or surgery

    Suprainguinal fascia iliaca plane block: The needle entering in plane from the caudal end of the ultrasound probe passes through the m. sartorius and into the musculus iliacus and fascia iliaca reaches. The fascia iliaca is passed with the needle and local anaesthetic solution is injected immediately under the fascia.

Study groups in NCT06001996
Study groupRoleWhat they receive
Pericapsular nerve group (PENG) blockGroup 1:Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the upper pubic ramus, and patients injected with local anesthetic solution. * After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. * After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied. * Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation. * Plane block applications will be applied only once in the preoperative period * Plane block applications will be performed by anaesthesiologists with at least 5 years of experience
Receives: Procedure: Pericapsular nerve group (PENG) block
Suprainguinal fascia iliaca plane blockGroup 2: Suprainguinal fascia iliaca plane block: Patients in whom the needle entered in plane from the caudal end of the ultrasound probe passes through the musculus iliacus and fascia iliaca and local anesthetic solution has been injected immediately under the fascia. After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied. Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation. * Plane block applications will be applied only once in the preoperative period * plane block applications will be performed by anaesthesiologists with at least 5 years of experience
Receives: Procedure: Suprainguinal fascia iliaca plane block

What is being measured

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

  1. Assessment of pain level

    Assessment of pain level with the Numerical Rating Scale (NRS) :

    The 11-point numerical scale ranges from '0' representing one pain end (e.g. "no pain") to '10' representing the other pain end (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: 1: measured in neutral position before the block. 2: measured with 15 degrees elevation of the affected limb before the block.3: Measured in spinal positioning. 4: Measured between 0-2 hours postoperatively. 5: Measured between 2-8 hours postoperatively

  2. Evaluation of ease of positioning

    It was determined by means of a scale scored from 0-3 (0=no positioning, 1=standing in abnormal posture due to pain and needing support for positioning 2=mild discomfort but no need for support for positioning 3=able to position on their own without pain).

    Measured: Procedure (at the stage of introduction of spinal anaesthesia)

Secondary outcomes (8)
  1. Agitation assessment

    Agitation assessment with Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.

    Measured: During positioning for spinal anaesthesia procedure

  2. mean blood pressure

    Mean blood pressure assessed using automatic sphygmomanometer over a 60 second interval

    Measured: Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)

  3. Heart rate

    The number of heart beats per minute obtained by electrocardiographic monitoring

    Measured: Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)

  4. Tramadol consumption after surgery

    Total amount of tramadol consumed within 24 hours after surgery

    Measured: 24 hours postoperatively

  5. Time of first analgesia use

    Duration of the first analgesic requirement after surgery (in hours)

    Measured: up to 24 hours (Duration of the first analgesic requirement after surgery (in hours))

  6. Limb range of motion

    Limb range of motion assessed using goniometer

    Measured: 1- Postoperative 4th hours , 2- Postoperative 8th hours

  7. Patient satisfaction score

    Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = quite unsatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory.

    Measured: Second postoperative day

  8. Number of Participants with Side effects

    Number of Participants with side effects such as neurological deficit, oedema, haematoma, nausea and vomiting will be evaluated by physical examination, patient anamnesis and nurse follow-up forms

    Measured: within 24 hours postoperatively

Timeline

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

  1. First posted21 Aug 2023
  2. Study start3 Oct 2023
  3. Primary completion29 Jan 2024
  4. Study completion30 Jan 2024

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
Cohort
Time perspective
Prospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001996
Sponsor's protocol ID
12.09.2022/265
Status last verified
Feb 2024
First submitted
10 Aug 2023
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.

    PubMed 35330408

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fracture, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 3 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: finished, as of the sponsor's last update on 6 Feb 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?

Assessment of pain level (time frame: 1: measured in neutral position before the block. 2: measured with 15 degrees elevation of the affected limb before the block.3: Measured in spinal positioning. 4: Measured between 0-2 hours postoperatively. 5: Measured between 2-8 hours postoperatively). 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 NCT06001996, which also lists 1 linked publication.

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 6 Feb 2024.

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