The Difference Between Using Local and General Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair

NCT06537518 | Completed

• 1 other identifier: RC 43-11-2023
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. ACB, which blocks the saphenous nerve and obturator nerve branches, is preferred over FNB due to its potential to decrease mobility and increase falls risk. Dexamethasone, a potent glucocorticoid, is used as an adjuvant for ACB, but its perineural administration may carry neurotoxicity risks. Some pain physicians prefer intravenous administration to prolong the action of local anesthetics used in peripheral nerve blocks.

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management.

  Value of administration of dexamethasone enhancing the analgesic action of bupivacaine used in ACB after arthroscopic management of the ACL.

  6 months

Study Arms (3)

IV anesthetic Group

ACTIVE COMPARATOR

Drug: Dexamethasone injection; Drug: Bupivacaine 0.375% Injectable Solution

Local anesthetic Group

ACTIVE COMPARATOR

Drug: Dexamethasone injection; Drug: Bupivacaine 0.5% Injectable Solution

Control Group

ACTIVE COMPARATOR

Drug: Bupivacaine 0.375% Injectable Solution

Interventions

Dexamethasone injection DRUG

Dexamethasone, a potent glucocorticoid, decreases the inflammatory response, tissue damage, and pain after surgical procedures; which can be injected locally or Intravenously.

IV anesthetic Group; Local anesthetic Group

Bupivacaine 0.375% Injectable Solution DRUG

Isobaric bupivacaine (0.375%) is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.

Control Group; IV anesthetic Group

Bupivacaine 0.5% Injectable Solution DRUG

20 ml of Bupivacain 0.5% was mixed with dexamethasone 8 mg is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.

Local anesthetic Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with ACL injury;
• Patients in class I, II according to American Society of Anesthesiologists (ASA) classification.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha faculty of Medicine

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Calcium Dobesilate; Bupivacaine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Pain, and ICU Department

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 5, 2024
• Study Start: May 1, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 25, 2022
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

EG (1)