NCT04423419

Brief Summary

The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

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

May 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

May 6, 2020

Last Update Submit

June 6, 2020

Conditions

Keywords

post operative painhip arthroscopy

Outcome Measures

Primary Outcomes (1)

  • evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy

    by question the patient about pain and its degree using visual analogue pain score( VAS score),it takes score from (0-10) according to severity of pain ,higher score indicates greater pain intensity.

    24 hours

Secondary Outcomes (1)

  • duration of the analgesic effect of the block

    24 hours

Study Arms (3)

A

OTHER

will undergo Peri -articular nerve group block for hip joint under ultrasound guide as analgesia post operative after hip arthroscopy

Procedure: PENG block

B

OTHER

will undergo ultrasound guided fascia iliaca block as postoperative analgesia after hip arthroscopy

Procedure: fascia iliaca block

C

OTHER

will receive ordinary IV analgesia during operation hip arthroscopy

Other: IV analgesia

Interventions

PENG blockPROCEDURE

The US probe placed in a transverse plane over the AIIS . the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25%

Also known as: injection of local anasthetics drug in peri-articular nerves of hip joint
A

ultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25%

Also known as: injection of local anathetics drug in fascia ilica space
B

IV analgesia

Also known as: no block
C

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy

You may not qualify if:

  • pregnancy or breast feeding
  • neurological deficits or neuropathy
  • opioid addict
  • local skin infections, bleeding diathesis, and coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1_ Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am 2012; 94: e23. 2_ Tan CO, Chong YM, Tran P et al. Surgical predictors of acute postoperative pain after hip arthroscopy. BMC Anesthesiol 2015; 15:96. 3- Jerry G. Xing,*yMD, MSc, FRCSC, Faraj W. Abdallah,zMD, Richard Brull,§MD, FRCPC,Stephanie Oldfield,§Andrew Dold,yMD, M. Lucas Murnaghan,||MD, MEd, FRCSC,and Daniel B. Whelan,{MD, FRCSC Preoperative Femoral Nerve Block for Hip Arthroscopy Randomized, Triple-Masked Controlled Trial The American Journal of Sports Medicine 2015 4_, Gardner E. The innervation of the hip joint. Anat Rec. 1948;101:353-371. 5_ Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular nerve group (PENG) block for hip fracture. RegAnesth Pain Med. 2018; 43(8):859-63. 6_ Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency procedures to relieve chronic hip pain. An evidence-based narrative review. Reg Anesth Pain Med. 2018;43:72-83. 7_S.M.White,R.Griffiths,J.Holloway,andA.Shannon,"AnaesthesiaforproximalfemoralfractureintheUK:firstreportfrom theNHShipfractureanaesthesianetwork,"Anaesthesia,vol.65, no.3,pp.243-248,2010.

    BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • essam sharkawy, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

safaa noaman, resident

CONTACT

mahmoud kamel, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the patient and the assessor will mask about type of block
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group A will undergo PENG block group B will undergo fascia iliaca block groupC will receive iv analgesia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

May 6, 2020

First Posted

June 9, 2020

Study Start

July 1, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

June 9, 2020

Record last verified: 2020-05