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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Ankle Block; Procedure: Sciatic nerve block

Detailed Description

Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.

After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.

The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Albrecht, PD Dr; Phone Number: +41 79 556 63 41; Email: eric.albrecht@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ankle Block; Ankle block will be performed under ultrasound guidance.	Procedure: Ankle Block; Ankle block will be performed prior to surgery under ultrasound guidance
Active Comparator: Popliteal sciatic nerve block (PSNB); PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle	Procedure: Sciatic nerve block; Sciatic nerve block will be performed prior to surgery under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	Time elapsed between block procedure and first iv request of morphine from PCA	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption at 24h postoperatively	Total consumption of morphine from PCA at 24 postoperative hours	24 hours after surgery
Pain score at rest at 4 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	4 hours after surgery
Pain score on movement at 4 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	4 hours after surgery
Pain score at rest at 12 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	12 hours after surgery
Pain score on movement at 12 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	12 hours after surgery
Pain score at rest at 24 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	24 hours after surgery
Pain score on movement at 24 postoperative hours	Pain score (visual analog scale, 0 = minimum; 10 = maximum)	24 hours after surgery
Block success rate	Success of block assessed by pinprick test	45 minutes after block procedure
Global patient satisfaction 48h after surgery	Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)	48 hours after surgery
Complications after block	Report of any intravascular injection or any sensory/motor anomalies	48 hours after surgery
Rate of neuropathic pain	Rate of patients describing neuropathic pain 4-6 weeks postoperatively	4-6 weeks postoperatively
Rate of paresthesia	Rate of patients complaining of paresthesia	Up to 24 hours after block procedure
Block procedure time	Time from first ultrasound image to needle withdrawal	Up to 10 minutes after ultrasound scanning

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Eric Albrecht, PD Dr, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CER-VD 2018-01090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No