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Anlgesia for Hip Arthroscopy by Assessing Quality of Different Type of Regional Block, Femoral Nerve Block Versus Fascia Iliaca BlockPhase 4NCT05010499

Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block

A Phase 4 study testing Levobupivacaine in people with Anlgesia for Hip Arthroscopy by Assessing Quality of Different Type of Regional Block, Femoral Nerve Block Versus Fascia Iliaca Block, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 21 to 45 years
What is being tested?
Levobupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
28 Jul 2021to 30 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • maha sadek El Derh

    Cairo

    maha S El Derh, MD, 01144866675, mahasadek81@yahoo.com

    mohamed Ali, MD, 01006512101, mohmourad1980@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Hip Arthroscopy; Femoral Nerve Block or Fascia Iliaca Block: A Randomized Control Trial

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 .

Read the 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.

Being tested
Levobupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevobupivacaineDrug

    Also called Bupivacaine hydrochloride (Marcaine)

    femoral nerve block receives 20 ml of levobupivacaine 0.25%

  • LevobupivacaineDrug

    Also called Bupivacaine Hydrochloride (Marcaine)

    Fascia iliaca block receives 40 ml of levobupivacaine 0.25%

Study groups in NCT05010499
Study groupRoleWhat they receive
Femoral nerve blockActive comparatorPatients will receive femoral nerve block (20 ml levobupivacaine 0.25%) after general anesthesia for hip arthroscpe
Receives: Drug: Levobupivacaine
Fascia iliaca blockActive comparatorPatients will receive fascia iliaca block (40 ml levobupivacaine 0.25%) after general anesthesia for hip arthroscpe
Receives: Drug: Levobupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 hours

Secondary outcomes (1)
  1. postoperative ability to ambulate.

    Assess the time patients start to ambulate postoperative.

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start28 Jul 2021
  3. Primary completion15 Nov 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
patients undergoing hip arthroscope are divided into 2 groups. patients either receive femoral nerve block or fascia iliaca block.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010499
Sponsor's protocol ID
FMASU R 143/2021
Status last verified
Aug 2021
First submitted
11 Aug 2021
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levobupivacaine in people with Anlgesia for Hip Arthroscopy by Assessing Quality of Different Type of Regional Block, Femoral Nerve Block Versus Fascia Iliaca Block, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Record the time patients require analgesia postoperatively (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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