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ACB Versus IA Analgesia in Knee Arthroscopy

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ClinicalTrials.gov Identifier: NCT04715152
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Seham Mohamed Moeen Ibrahim, Assiut University

Study Description
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Brief Summary:
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: ACB with levobupivacaine and dexamethasone Drug: IA analgesia with levobupivacaine and dexamethasone Phase 2

Detailed Description:

Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours.

Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. In addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. Systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects.

The saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. Although adductor canal block (ACB) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (FNB).

Intra-articular (IA) local anesthetic agents have been used either alone or in combination with other agent. However, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug.

Levobupivacaine, the S-enantiomer of bupivacaine is a comparatively newer local anesthetic agent introduced into clinical practice and it also possesses less cardiac and neural toxicity. Levobupivacaine has been shown to be safe and effective for epidural and spinal anesthesia and blockade of the brachial plexus.

Dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. It blocks the nociceptive impulse transmission along the myelinated C fibers. Dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ACB group
Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.
 Drug: ACB with levobupivacaine and dexamethasone
Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline
Placebo Comparator: IA group
Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.
 Drug: IA analgesia with levobupivacaine and dexamethasone
Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline


Outcome Measures
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Primary Outcome Measures :
  1. The pain free time after surgery [ Time Frame: 24 hours after surgery ]
    Assessed using the visual analogue scale of pain graded from 0 = no pain to 10 = maximum pain


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old

Exclusion Criteria:

  • Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
  • History of cardiovascular, cerebrovascular, and respiratory diseases
  • Preexisting neuropathies
  • Chronic pain syndrome
  • Opioid dependence
  • Patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction
  • Pregnancy
  • Preoperative inability to perform the mobilization test (TUG test)
  • Not willingness to participate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715152


Contacts
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Contact: Seham M Moeen, MD 01006386324 ext 02 seham.moeen@yahoo.com
Contact: Shaymaa R Zarea 01027092629 ext 02 shaymaazarea1@gmail.com

Locations
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Egypt
Seham Mohamed Moeen Recruiting
Assiut, Egypt, 71515
Contact: Seham M Moeen, MD    01006386324 ext 02    seham.moeen@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Seham M Moeen, MD Assiut University
More Information
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Responsible Party: Seham Mohamed Moeen Ibrahim, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04715152    
Other Study ID Numbers: SM 1 2021
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Dexamethasone acetate
Levobupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents