Effect of Combining Peri-hamstring Injection or Anterior Obturator Nerve Block on the Analgesic Efficacy of Adductor Canal Block for Arthroscopic Anterior Cruciate Ligament Reconstruction Under General Anesthesia

NCT06398717 | Not Yet Recruiting

• 1 other identifier: MD291/2023
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain after anterior cruciate ligament reconstruction with autologous hamstring graft can be attributed to both arthroscopic surgery and the graft donor site. Many methods are available to provide postoperative analgesia for patients undergoing total knee arthroplasty, but it is unclear how they compare with each other. The extent to which the two techniques anterior division obturator nerve block vs peritendinous hamstring injection may benefit the patients in terms of overall analgesia and specifically the autograft site analgesia needs evaluation.

Conditions

Adductor Canal Block

Outcome Measures

Primary Outcomes (1)

• post operative pain control

  The postoperative visual analogue scale pain score.( from 0 to 10, 0 being "no pain" and 10 being "worst possible pain." )

  6 hours

Secondary Outcomes (6)

• pain controlling methods

  24 hours

• pain controlling methods

  24 hours

• pain controlling methods

  24 hours

• pain controlling methods

  24 hours

• pain controlling methods

  24 hours

Study Arms (3)

group C: will receive unilateral adductor canal block alone

ACTIVE COMPARATOR

Procedure: adductor canal block

group H:will receive unilateral peri-hamstring injection combined to adductor canal block

ACTIVE COMPARATOR

Procedure: adductor canal block

group O: will receive unilateral anterior obturator nerve block combined to adductor canal block

ACTIVE COMPARATOR

Procedure: adductor canal block

Interventions

adductor canal block PROCEDURE

group C will receive a unilateral adductor canal block alone, using an ultrasound to identify the location of the nerve. group H will receive unilateral peri-hamstring injection combined to adductor canal block, After the adductor canal block, the transducer will be moved posteriorly till identifying the site of injection group O will receive unilateral anterior obturator nerve block combined with adductor canal block, The anterior branch of the obturator nerve is located using ultrasound

Also known as: obturator canal block, peri-hamestring injection

group C: will receive unilateral adductor canal block alone; group H:will receive unilateral peri-hamstring injection combined to adductor canal block; group O: will receive unilateral anterior obturator nerve block combined to adductor canal block

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70 years
• Both sex
• Patients scheduled for elective arthroscopic anterior cruciate ligament reconstruction under general anesthesia.
• American Society of Anesthesiologists Physical Status Class I, II Patients.
• Body Mass Index \<30 kg/m2.

You may not qualify if:

• History of allergy to the study medications.
• American Society of Anesthesiologists class ≥III.
• Patients refusal to participate in the study.
• The inability to comprehend or participate in the pain scoring system.
• Contraindications to regional anesthesia (including coagulopathy and local infection).
• Psychiatric disorder and patient with any neurological disorder.
• Opioid tolerance or dependence.
• Distorted anatomy.
• Peripheral neuropathy.
• Renal or hepatic impairment.
• Morbid obesity (Body Mass Index: \>30kg/m2).

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Mohamed Ibrahim El-Desoukey, Master degree

CONTACT

0201064988842; mohamed.i.eldesoukey@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share