The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
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|ClinicalTrials.gov Identifier: NCT02697955|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arthrosis Arthritis||Drug: Bupivacaine-epinephrine Other: Placebo||Phase 4|
Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.
This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery|
|Actual Study Start Date :||June 21, 2016|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine
50 mg bupivacaine and 50 μg adrenalin
Placebo Comparator: Placebo
10 ml normal saline water (sodium chloride solution, 0,9%)
9 mg sodium chloride pr. ml (0,9 %)
Other Name: Sodium chloride solution
- Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain) [ Time Frame: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery. ]Pain scores evaluated using NRS (numeric rating scale). Significant pain is defined as NRS > 3 from the anterior and/medial side of the ankle joint. In case of significant pain, patients receive a rescue saphenous block with 10 ml bupivacaine-adrenaline.
- Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen) [ Time Frame: At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min. ]Test of nociceptive response in the cutaneous innervation area of the infrapatellar branch (branch of the saphenous nerve). The test is performed in an area from the medial femoral condyle to the midline between the apex of patella and tibial tuberosity.
- Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen) [ Time Frame: Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery) ]Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697955
|Department of Anesthesiology, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Study Director:||Thomas Fichtner Bendtsen, MD, phD||Department of Anesthesiology, Aarhus University Hospital|