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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04423419
Other study ID # postoperative pain
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date April 1, 2022

Study information

Verified date May 2020
Source Assiut University
Contact safaa noaman, resident
Phone 201030333468
Email safa2gmsy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

In recent decades hip arthroscopy gained popularity and the number of procedures increase every year , due to the widening range of indications, as femoroacetabular impingement, labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after hip arthroscopy due to several factors. divided in two regions. First the intra-articular where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony resection. Outside the joint caused by traction, the portal tracts and extravasation of irrigation , soft tissue swelling.

the hip joint found to be innervated from the femoral nerve for its anterior part, the obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the nerve to the quadratus femoris muscle for its postero-medial par

Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory obturator and femoral nerve Also, it could spread to block the obturator nerve and its articular branches the high articular branches from FN and AON are found between the anterior inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.

The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with the space between quadratus lumborum muscle and its fascia . Three important nerves for hip innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral cutaneous nerve


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- pregnancy or breast feeding

- neurological deficits or neuropathy

- opioid addict

- local skin infections, bleeding diathesis, and coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PENG block
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%
fascia iliaca block
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%
Other:
IV analgesia
IV analgesia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 duration of the analgesic effect of the block evaluate duration of the analgesic effect of the block by calculating The time passed from block to the patient first analgesia request and total cumulative doses of analgesia 24 hours
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