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ACB Versus IA Analgesia in Knee Arthroscopy

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Postoperative Pain

Treatments

Drug: IA group
Drug: ACB group

Study type

Interventional

Funder types

Other

Identifiers

NCT04715152
SM 1 2021

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
  • Not willingness to participate.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

ACB group
Active Comparator group
Description:
Patients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.
Treatment:
Drug: ACB group
IA group
Placebo Comparator group
Description:
Patients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.
Treatment:
Drug: IA group

Trial contacts and locations

1

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Central trial contact

Seham M Moeen, MD; Shaymaa R Zarea

Data sourced from clinicaltrials.gov

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