NCT05256056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

February 16, 2022

Last Update Submit

June 1, 2022

Conditions

Keywords

pericapsular nerve group blockfemur fracturepostoperative analgesia

Outcome Measures

Primary Outcomes (2)

  • visual analouge scale

    the VAS 0 means no pain, 10 means the worst pain possible

    up to 24 hours,

  • pin-prick test

    the ability to determine the difference between sharp and dull.

    up to 20 minutes

Secondary Outcomes (2)

  • cold sensation test

    up to 20 minutes

  • presence of quadriceps motor block

    up to 24 hours

Study Arms (2)

Group A

EXPERIMENTAL

patients will be injected with 20 cc of 0.25% Bupivacaine

Drug: Bupivacain

Group B

EXPERIMENTAL

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

Drug: Bupivacain

Interventions

efficacy of bupivacaine in different volumes

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Research and Training Hospital

Seyrantepe, Istanbul, 34567, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 34196965BACKGROUND
  • 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.

    PMID: 32232662BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeFemoral Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • leyla kılınç

    şişli etfal eğitim araştırma hastanesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

February 25, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations