Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

NCT03683342 | Completed

• 1 other identifier: CER-VD 2018-01090
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  Time elapsed between block procedure and first iv request of morphine from PCA

  24 hours after surgery

Secondary Outcomes (13)

• Total opioid consumption at 24h postoperatively

  24 hours after surgery

• Pain score at rest at 4 postoperative hours

  4 hours after surgery

• Pain score on movement at 4 postoperative hours

  4 hours after surgery

• Pain score at rest at 12 postoperative hours

  12 hours after surgery

• Pain score on movement at 12 postoperative hours

  12 hours after surgery

Study Arms (2)

Ankle Block

ACTIVE COMPARATOR

Ankle block will be performed under ultrasound guidance.

Procedure: Ankle Block

Popliteal sciatic nerve block (PSNB)

ACTIVE COMPARATOR

PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle

Procedure: Sciatic nerve block

Interventions

Ankle Block PROCEDURE

Ankle block will be performed prior to surgery under ultrasound guidance

Ankle Block

Sciatic nerve block PROCEDURE

Sciatic nerve block will be performed prior to surgery under ultrasound guidance

Popliteal sciatic nerve block (PSNB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are going to undergo a unilateral forefoot surgery ;
• ASA I-III ;
• Aged 18 years or more;
• Weighing at least 45 kg

You may not qualify if:

• Patient refusal and/or language/cognitive barrier
• Pregnancy
• Contra-indication for regional anesthesia
• Opiate or alcohol dependency
• Concomitant oncological disease with chemotherapy
• Patients suffering from neuropathic pain

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.

  PMID: 37972929 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Eric Albrecht, PD Dr

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program director of regional anesthesia

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: September 20, 2018
• Primary Completion: November 1, 2022
• Study Completion: December 30, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)