ACB Versus IA Analgesia in Knee Arthroscopy

May 12, 2021 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Seham Mohamed Moeen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2021

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

August 20, 2021

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM 1 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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