- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03239314
Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy
The Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Postoperative Analgesia Following Knee Arthroscopic Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion of any signs of toxicity or nerve injury, the patients operations were done under spinal anesthesia. Patients were allocated into one of 2 groups (30 patients per group).
I. Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml normal saline.
ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).
Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively for 24 h.
Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia. Time to first request for analgesia & total dose of rescue analgesia were be recorded.
10. Satisfaction score will be measured on a linear numerical scale; ranging from 0 = complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like nausea, vomiting, bradycardia, hypotension will be also documented. The time to first analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative, 6, 12, 18, and 24 h postoperative from zero to 5.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction
Exclusion Criteria:
- patient refusal
- drug allergy
- failed procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group I
Group I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively.
|
Injected in the adductor canal
Other Names:
|
Active Comparator: group II
Group II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively.
|
Injected in the adductor canal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of postoperative analgesia
Time Frame: One day postoperative
|
assessed by pain score
|
One day postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative analgesic consumption
Time Frame: One day postoperative
|
postoperative opioid consumption
|
One day postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
- Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Pharmaceutical Solutions
Other Study ID Numbers
- 17100210
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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