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Volume Dependent Effect of Pericapsular Nerve Block

Primary Purpose

Post Operative Pain, Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacain
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring pericapsular nerve group block, femur fracture, postoperative analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sisli Etfal Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

patients will be injected with 20 cc of 0.25% Bupivacaine

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

Outcomes

Primary Outcome Measures

visual analouge scale
the VAS 0 means no pain, 10 means the worst pain possible
pin-prick test
the ability to determine the difference between sharp and dull.

Secondary Outcome Measures

cold sensation test
feel the cold: 0, not feel : 1
presence of quadriceps motor block
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

Full Information

First Posted
February 16, 2022
Last Updated
June 1, 2022
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05256056
Brief Title
Volume Dependent Effect of Pericapsular Nerve Block
Official Title
Comparison of the Volume Dependent Effect of Pericapsular Nerve Block in Patients Operated for Femur Fracture: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Femur Fracture
Keywords
pericapsular nerve group block, femur fracture, postoperative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
patients will be injected with 20 cc of 0.25% Bupivacaine
Arm Title
Group B
Arm Type
Experimental
Arm Description
patients will be injected with 30 cc of 0.25% Bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
efficacy of bupivacaine in different volumes
Primary Outcome Measure Information:
Title
visual analouge scale
Description
the VAS 0 means no pain, 10 means the worst pain possible
Time Frame
up to 24 hours,
Title
pin-prick test
Description
the ability to determine the difference between sharp and dull.
Time Frame
up to 20 minutes
Secondary Outcome Measure Information:
Title
cold sensation test
Description
feel the cold: 0, not feel : 1
Time Frame
up to 20 minutes
Title
presence of quadriceps motor block
Description
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
leyla kılınç
Organizational Affiliation
şişli etfal eğitim araştırma hastanesi
Official's Role
Study Chair
Facility Information:
Facility Name
Sisli Etfal Research and Training Hospital
City
Seyrantepe
State/Province
Istanbul
ZIP/Postal Code
34567
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34196965
Citation
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.
Results Reference
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PubMed Identifier
32232662
Citation
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.
Results Reference
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Volume Dependent Effect of Pericapsular Nerve Block

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