Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block

NCT05010499 | Unknown Phase 4 DMC

• 1 other identifier: FMASU R 143/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing hip arthroscopy will be divided into 2 groups after receiving general anesthesia. 1 group will receive femoral nerve block and the other one will receive fascia iliaca block. Postoperative total rescue analgesia will recorded in both groups, and in which group early ambulation will take place .

Conditions

Anlgesia for Hip Arthroscopy by Assessing Quality of Different Type of Regional Block, Femoral Nerve Block Versus Fascia Iliaca Block

Outcome Measures

Primary Outcomes (1)

• Record the time patients require analgesia postoperatively

  Assessment of postoperative pain score by Visual analogue Scale (VAS) and the time of demand for first rescue analgesia

  12 hours

Secondary Outcomes (1)

• postoperative ability to ambulate.

  24 hours postoperative

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

Patients will receive femoral nerve block (20 ml levobupivacaine 0.25%) after general anesthesia for hip arthroscpe

Drug: Levobupivacaine

Fascia iliaca block

ACTIVE COMPARATOR

Patients will receive fascia iliaca block (40 ml levobupivacaine 0.25%) after general anesthesia for hip arthroscpe

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

femoral nerve block receives 20 ml of levobupivacaine 0.25%

Also known as: Bupivacaine hydrochloride (Marcaine)

Femoral nerve block

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 21 and 45 years ,ASA I and II undergoing hip arthroscope.

You may not qualify if:

• Age less than 21 or more than 45 years
• ASA IV
• Those who have an emergency surgery, or patients scheduled for complicated surgeries
• Those who have a history of allergy to levobupivacaine
• local skin site infections.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

maha sadek El Derh

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Levobupivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither the patients nor the treating doctor know the type of block patient received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: patients undergoing hip arthroscope are divided into 2 groups. patients either receive femoral nerve block or fascia iliaca block.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: July 28, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 30, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

EG (1)