Volume Dependent Effect of Pericapsular Nerve Block

NCT ID: NCT05256056

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2022-06-01

Brief Summary

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In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Detailed Description

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Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.

By PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Conditions

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Post Operative Pain Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A patients will be injected with 20 cc of 0.25% Bupivacaine, and Group B patients will be injected with 30 cc of 0.25% Bupivacaine
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patients will be randomized using the closed envelope method. While the practitioner knows the interventions to be made, the data collector will collect the data without learning the patient's group.

Study Groups

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Group A

patients will be injected with 20 cc of 0.25% Bupivacaine

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

efficacy of bupivacaine in different volumes

Group B

patients will be injected with 30 cc of 0.25% Bupivacaine.

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

efficacy of bupivacaine in different volumes

Interventions

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Bupivacain

efficacy of bupivacaine in different volumes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergoing hip arthroplasty surgery
* Patients over the age of 18
* ASA I-II-III patients
* Patients who will be operated under spinal anesthesia

Exclusion Criteria

* ASA IV patients, Pregnant women
* Patients who are not suitable for spinal anesthesia
* Patients diagnosed with Alzheimer's and dementia who cannot cooperate
* Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)
* Patients who do not want to participate in the study
* Patients under the age of 18
* Patients switched to general anesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gamze Dilara Demir

specialist medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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leyla kılınç

Role: STUDY_CHAIR

şişli etfal eğitim araştırma hastanesi

Locations

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Sisli Etfal Research and Training Hospital

Seyrantepe, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

Reference Type BACKGROUND
PMID: 34196965 (View on PubMed)

Sandri M, Blasi A, De Blasi RA. PENG block and LIA as a possible anesthesia technique for total hip arthroplasty. J Anesth. 2020 Jun;34(3):472-475. doi: 10.1007/s00540-020-02768-w. Epub 2020 Mar 30.

Reference Type BACKGROUND
PMID: 32232662 (View on PubMed)

Other Identifiers

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2021/516

Identifier Type: -

Identifier Source: org_study_id

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