Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05010499
Collaborator
(none)
30
1
2
4.1
7.3

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
patients undergoing hip arthroscope are divided into 2 groups. patients either receive femoral nerve block or fascia iliaca block.patients undergoing hip arthroscope are divided into 2 groups. patients either receive femoral nerve block or fascia iliaca block.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
neither the patients nor the treating doctor know the type of block patient received.
Primary Purpose:
Treatment
Official Title:
Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block: A Randomized Control Trial
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Nov 15, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Femoral nerve block

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

Drug: Levobupivacaine
femoral nerve block receives 20 ml of levobupivacaine 0.25%
Other Names:
  • Bupivacaine hydrochloride (Marcaine)
  • Active Comparator: Fascia iliaca block

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

    Drug: Levobupivacaine
    Fascia iliaca block receives 40 ml of levobupivacaine 0.25%
    Other Names:
  • Bupivacaine Hydrochloride (Marcaine)
  • Outcome Measures

    Primary Outcome Measures

    1. Record the time patients require analgesia postoperatively [12 hours]

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

    Secondary Outcome Measures

    1. postoperative ability to ambulate. [24 hours postoperative]

      Assess the time patients start to ambulate postoperative.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 maha sadek El Derh Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    maha sadek El Derh, Lecturer of Anesthesia, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05010499
    Other Study ID Numbers:
    • FMASU R 143/2021
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2021