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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Arthritis; Arthrosis

Treatments: Drug: Bupivacaine-epinephrine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02697955

ProtokolSB2

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Bupivacaine-epinephrine

Experimental group

Description:

10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine

Treatment:

Drug: Bupivacaine-epinephrine

Placebo

Placebo Comparator group

Description:

10 ml normal saline water (sodium chloride solution, 0,9%)

Treatment:

Other: Placebo