ACB Versus IA Analgesia in Knee Arthroscopy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
ACB with levobupivacaine and dexamethasone
IA analgesia with levobupivacaine and dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility 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.
Sites / Locations
- Seham Mohamed MoeenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACB group
IA group
Arm Description
Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.
Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.
Outcomes
Primary Outcome Measures
The pain free time after surgery
Assessed using the visual analogue scale of pain graded from 0 = no pain to 10 = maximum pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04715152
Brief Title
ACB Versus IA Analgesia in Knee Arthroscopy
Official Title
Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
August 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACB group
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.
Arm Title
IA group
Arm Type
Placebo Comparator
Arm Description
Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.
Intervention Type
Drug
Intervention Name(s)
ACB with levobupivacaine and dexamethasone
Intervention Description
Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline
Intervention Type
Drug
Intervention Name(s)
IA analgesia with levobupivacaine and dexamethasone
Intervention Description
Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline
Primary Outcome Measure Information:
Title
The pain free time after surgery
Description
Assessed using the visual analogue scale of pain graded from 0 = no pain to 10 = maximum pain
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaymaa R Zarea
Phone
01027092629
Ext
02
Email
shaymaazarea1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seham Mohamed Moeen
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
ACB Versus IA Analgesia in Knee Arthroscopy
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