- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240402
Compare Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided ACB for Postoperative Analgesia After Knee Surgeries
Comparative Study of Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-Guided Adductor Canal Block for Postoperative Analgesia After Knee Surgeries
Study Overview
Status
Intervention / Treatment
Detailed Description
Knee surgeries are frequently performed operations that can lead to intense pain after the procedure (1). Early mobilization following knee surgery is associated with improved functional outcomes and a reduction in postoperative complications. As a result, achieving effective pain relief while preserving motor function is a primary goal in postoperative care for knee procedures (2).
A variety of strategies are employed for managing postoperative pain, including systemic opioid administration, epidural anesthesia, peripheral nerve blocks, and local infiltration of anesthetics (3).
However, systemic opioids are linked to several undesirable side effects such as nausea, vomiting, itching, sedation, and respiratory depression, which may hinder rehabilitation.
Similarly, epidural analgesia often results in complications like hypotension, urinary retention, and pruritus. The use of long-acting intrathecal opioids has also been associated with adverse events including bilateral motor blockade, tremors, and hypotension. Due to these issues, the reliance on systemic and intrathecal methods for postoperative pain control has been declining (4).
The adductor canal block (ACB), which targets the Hunter's canal, anesthetizes the saphenous and vastus medialis nerves, along with partial coverage of other sensory nerves like the femoral nerve, medial cutaneous nerve, and branches of the obturator nerve as they traverse the distal canal (5). ACB is largely considered a sensory block, affecting only the motor nerve to the vastus medialis, making it advantageous in preserving quadriceps strength during recovery (6, 7). Bupivacaine, a widely used long-acting amide local anesthetic, is frequently employed in peripheral nerve blocks such as the ACB due to its favorable pharmacokinetics.
Nonetheless, its analgesic duration may be insufficient for managing postoperative pain in surgeries with high nociceptive intensity (8). To extend its efficacy and enhance analgesic quality, several adjunctive agents have been explored, including opioids and α2-adrenergic agonists (9).
Morphine, a traditional opioid analgesic, acts on μ-opioid receptors to prolong analgesia and reduce local anesthetic requirements. Despite its effectiveness, its use is limited by opioid-related adverse effects like nausea, vomiting, pruritus, and respiratory depression. Furthermore, some studies report that morphine may not significantly improve postoperative pain control or functional recovery after knee surgery (10-12).
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been increasingly studied as an adjuvant in peripheral nerve blocks. When administered
perineurally, it has demonstrated potential to accelerate onset, prolong analgesia, reduce postoperative pain intensity, and minimize systemic opioid use, all while producing fewer systemic side effects (13). Its peripheral analgesic properties are thought to result from direct binding to α2-receptors at the nerve site (14).
Currently, there is limited research directly comparing the efficacy of morphine versus dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided ACB for postoperative analgesia following knee surgeries.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Ashraf Abd El-Nasser Abd El-Hamid kamel El Rewany Anesthesia KafrElsheikh University Faculty of Medicine Anesthesia, Surg, MBBCH
- Phone Number: +201061195395
- Email: ashraf.elrewany2@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Body mass index (BMI) of 20-35 kg/m2.
- Undergoing knee surgeries under spinal anesthesia.
Exclusion criteria:
- Any known allergy or contraindication to local anesthetic.
- History of substance abuse.
- Decompansated cardiac, pulmonary, hepatic, renal disease.
- Obese patients with BMI>35kg/m2.
- Pregnant and lactating mothers.
- Coagulopathies.
- Local skin infections at the site of injection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group D
Patients will receive ACB using 20 ml of bupivacaine 0.25%+ 0.5 µg/kg dexmedetomidine.
|
This study aims to compare morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided ACB for postoperative analgesia after knee surgeries. Primary outcome: • Time to first rescue analgesia . Secondary outcomes:
Other Names:
|
|
Experimental: Group M
Patients will receive ACB using 20 ml of bupivacaine 0.25% +0.1 mg/kg morphine. |
This study aims to compare morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided ACB for postoperative analgesia after knee surgeries. Primary outcome: • Time to first rescue analgesia . Secondary outcomes:
Other Names:
|
|
Experimental: Group C
Patients will receive ACB using 20 ml of bupivacaine 0.25% alone as a control group.
|
This study aims to compare morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided ACB for postoperative analgesia after knee surgeries. Primary outcome: • Time to first rescue analgesia . Secondary outcomes:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome:
Time Frame: 24 hours postoperatively.
|
• Time to first rescue analgesia .
|
24 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KafrelsheikhU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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