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

NCT ID: NCT06537518

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-25

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

Study Design

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

Study Groups

IV anesthetic Group

Group Type: ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type: DRUG

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

Bupivacaine 0.375% Injectable Solution

Intervention Type: 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.

Local anesthetic Group

Group Type: ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type: DRUG

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

Bupivacaine 0.5% Injectable Solution

Intervention Type: 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.

Control Group

Group Type: ACTIVE_COMPARATOR

Bupivacaine 0.375% Injectable Solution

Intervention Type: 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.

Interventions

Dexamethasone injection

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

Intervention Type: DRUG

Bupivacaine 0.375% Injectable Solution

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

Intervention Type: DRUG

Bupivacaine 0.5% Injectable Solution

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Sharara

Lecturer of Anesthesiology, Pain, and ICU Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha faculty of Medicine

Banhā, El Qalyoubia, Egypt

Countries

Egypt

Other Identifiers

RC 43-11-2023

Identifier Type: -

Identifier Source: org_study_id