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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683342
• Other study ID #: CER-VD 2018-01090
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Ankle Block
Ankle block will be performed prior to surgery under ultrasound guidance
• Sciatic nerve block
Sciatic nerve block will be performed prior to surgery under ultrasound guidance

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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