NCT04022057

The Impact of a Preoperative Nerve Block in Foot and Ankle Surgery on the Consumption of Sevoflurane

Withdrawn Phase 2, PHASE3 Last updated 6 June 2024

What this trial tests

Phase 2, PHASE3 trial testing Ropivacaine injection in Ankle Arthropathy. Withdrawn.

Timeline

1 August 2019

Primary endpoint
15 March 2020

15 March 2020

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Start date	1 August 2019
Primary completion	15 March 2020
Estimated completion	15 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Ropivacaine injection — full drug profile →
• Dextrose 5

Conditions studied

• Ankle Arthropathy — all drugs for Ankle Arthropathy →
• Anesthesia; Functional — all drugs for Anesthesia; Functional →
• Ankle Arthritis — all drugs for Ankle Arthritis →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Ankle Arthropathy or Anesthesia; Functional. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Reconstructive foot and ankle surgery is performed under general anesthesia. Included in this spectrum of surgery are ankle arthroplasties, various fusions, corrective arthrodesis, and more. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. For the region of the foot and ankle to be fully frozen, both the sciatic nerve and the saphenous nerve must be successfully blocked. Sciatic nerve blockade is most commonly achieved by blocking the nerve in the popliteal fossa. This block is named popliteal nerve block.

The investigators will examine and quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve blocks are applied before or after surgery. Patients will have two nerve block catheters (popliteal and saphenous catheter) placed under ultrasound-guidance prior to the case by an experienced and specifically trained anesthesiologist. The catheters will be loaded with a solution to which the anesthesiologist is blinded. It will either be local anesthetic or 5% dextrose (sham). The general anesthetic will be conducted according to a research protocol with anesthetic depth being the targeted endpoint. Measurements of the required MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes by a study team member. At the end of the case the anesthesiologist will be unblinded to the solution. Should the patient have received sham initially, they will now receive the full dose of local anesthetic prior to being woken up.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.