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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Ankle Block; Procedure: Sciatic nerve block

• Registration Number: NCT03683342
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

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 Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle Block	Ankle Block	Ankle block will be performed under ultrasound guidance.
Popliteal sciatic nerve block (PSNB)	Sciatic nerve block	PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	24 hours after surgery	Time elapsed between block procedure and first iv request of morphine from PCA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland