Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block

NCT ID: NCT05010499

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2021-11-30

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 .

Detailed Description

Patients undergoing hip arthaoscope will be conducted to operating room, where standard intraoperative monitoring will be applied, pulse oximetry, 5 lead ECG then peripheral cannulation. Anesthesia will be induced with fentanyl 1.5μg/kg, midazolam 0.1-0.5 mg/kg, cis-atracurium 0.15 mg/kg followed by intubation. Then anesthesia will be maintained with isoflurane1-1.5% Patients will be divided into two groups according to the randomization envelopes:

Group (A) :( 15 patients) the fascia iliaca block: Patient in the supine position, skin will be disinfected and linear transducer (8-12 MHZ) will be positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer will be moved laterally until the sartorius muscle is identified. Echogenic needle (Bajunk, 80 m.m length) will be inserted in-plane, as it will pass through fascia iliaca, the fascia will be first seen indented by the needle. While piercing the fascia, a "pop" may be felt, and the fascia may be seen to "snap" back on the US image (SONOSITE). After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane between the fascia and the iliopsoas muscle. A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described. Releasing the pressure of the transducer may reduce the resistance to injection and improve the distribution of local anesthetic. If the spread is deemed inadequate, additional injections laterally or medially to the original needle insertion or injection can be made to facilitate the medial-lateral spread (the injection is stopped and the needle repositioned before continuing. Additional injections may be made to ensure adequate spread) (Yun MJ, et al., 2009). 40 mL of 0.25% levobupivacaine will be given. The success of the nerve block is best predicted by documenting the spread of local anesthetic toward the femoral nerve medially and underneath the sartorius muscle laterally (L. Hanna, et al., 2014).

Group (B): Control group, (15 patients) femoral nerve block: With the patient in the supine position, the skin over the femoral crease will be disinfected and the transducer will be positioned to identify the femoral artery and nerve. If the nerve is not immediately apparent lateral to the artery, tilting the transducer proximally or distally often helps to image and highlight the nerve from the iliacus muscle and the more superficial adipose tissue. Once the femoral nerve is identified, the needle will be inserted in-plane in a lateral to medial orientation and advanced toward the femoral nerve (Mariano E.R ,et al., 2013). Once the needle tip is adjacent (either above, below, or lateral) to the nerve, and after careful aspiration, 1-2 mL of local anesthetic will be injected to confirm proper needle placement that will push the femoral nerve away from the injection followed by total volume of 20 ml 0.25% levobupivacaine (Lamaroon A. et al., 2014) The blocks will be performed by the expert anesthesia staff, and then positioning of patients will be done for the hip arthroscopy. Another blinded doctor to the type of block received will attend the surgery and manage and record any additional intraoperative analgesic requirements.

Postoperatively, timing for the first rescue analgesia will be recorded, if VAS is more than 5, 25 mg pethidine will be given. If no improvement second rescue analgesia in form 5 mg morphine will be given .Also total narcotics demand will be recorded with measurement of (VAS) hourly in the first 4 hours postoperatively then every 4 hours for 8 hours .Early ambulation will be assessed and recorded together with assessing the weakness of quadriceps femoris.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Femoral nerve block

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

femoral nerve block receives 20 ml of levobupivacaine 0.25%

Fascia iliaca block

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

Fascia iliaca block receives 40 ml of levobupivacaine 0.25%

Interventions

Levobupivacaine

femoral nerve block receives 20 ml of levobupivacaine 0.25%

Intervention Type: DRUG

Levobupivacaine

Fascia iliaca block receives 40 ml of levobupivacaine 0.25%

Intervention Type: DRUG

Other Intervention Names

Bupivacaine hydrochloride (Marcaine); Bupivacaine Hydrochloride (Marcaine)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

maha sadek El Derh

Lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

maha sadek El Derh

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

maha S El Derh, MD

Role: primary

mahasadek81@yahoo.com

01144866675

mohamed Ali, MD

Role: backup

mohmourad1980@gmail.com

01006512101

Other Identifiers

FMASU R 143/2021

Identifier Type: -

Identifier Source: org_study_id