The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

Arthritis Clinical Trial

Official title:

The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697955
• Other study ID #: ProtokolSB2
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2016
• Last updated: March 24, 2017
• Start date: June 21, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: September 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis

• Age = 18

• American Society of Anaesthesiology Classification I-III

• Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Exclusion Criteria:

• Communication problems or dementia

• Allergies to any medical product used in the study

• Neuropathy of the sciatic or femoral nerve prior to the operation

• Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease

• Daily use of opioids

• Coagulation disorders

• Infection at the site of injection or systemic infection

Related Conditions & MeSH terms

• Arthritis
• Arthrosis
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine-epinephrine
50 mg bupivacaine and 50 µg adrenalin

Other:
• Placebo
9 mg sodium chloride pr. ml (0,9 %)

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

Bendtsen TF, Moriggl B, Chan V, Børglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. — View Citation

Blumenthal S, Borgeat A, Neudörfer C, Bertolini R, Espinosa N, Aguirre J. Additional femoral catheter in combination with popliteal catheter for analgesia after major ankle surgery. Br J Anaesth. 2011 Mar;106(3):387-93. doi: 10.1093/bja/aeq365. — View Citation

Chen J, Lesser J, Hadzic A, Resta-Flarer F. The importance of the proximal saphenous nerve block for foot and ankle surgery. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):372. doi: 10.1097/AAP.0b013e318295596a. — View Citation

Clendenen SR, Whalen JL. Saphenous nerve innervation of the medial ankle. Local Reg Anesth. 2013 Mar 6;6:13-6. doi: 10.2147/LRA.S42603. — View Citation

Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Børglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. — View Citation

Kalthur SG, Sumalatha S, Nair N, Pandey AK, Sequeria S, Shobha L. Anatomic study of infrapatellar branch of saphenous nerve in male cadavers. Ir J Med Sci. 2015 Mar;184(1):201-6. doi: 10.1007/s11845-014-1087-2. — View Citation

Kerver AL, Leliveld MS, den Hartog D, Verhofstad MH, Kleinrensink GJ. The surgical anatomy of the infrapatellar branch of the saphenous nerve in relation to incisions for anteromedial knee surgery. J Bone Joint Surg Am. 2013 Dec 4;95(23):2119-25. doi: 10.2106/JBJS.L.01297. Review. — View Citation

White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-9. Erratum in: Anesth Analg. 2003 Dec;97(6):1557. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)	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.	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.
Secondary	Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)	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.	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.
Secondary	Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)	Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.	Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)