Clinical trial NCT03683342: Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
Official title: Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Total opioid consumption at 24h postoperatively
timeFrame: 24 hours after surgery
measure: Pain score at rest at 4 postoperative hours
timeFrame: 4 hours after surgery
measure: Pain score on movement at 4 postoperative hours
timeFrame: 4 hours after surgery
measure: Pain score at rest at 12 postoperative hours
timeFrame: 12 hours after surgery
measure: Pain score on movement at 12 postoperative hours
timeFrame: 12 hours after surgery
measure: Pain score at rest at 24 postoperative hours
timeFrame: 24 hours after surgery
measure: Pain score on movement at 24 postoperative hours
timeFrame: 24 hours after surgery
measure: Block success rate
timeFrame: 45 minutes after block procedure
measure: Global patient satisfaction 48h after surgery
timeFrame: 48 hours after surgery
measure: Complications after block
timeFrame: 48 hours after surgery
measure: Rate of neuropathic pain
timeFrame: 4-6 weeks postoperatively
measure: Rate of paresthesia
timeFrame: Up to 24 hours after block procedure
measure: Block procedure time
timeFrame: Up to 10 minutes after ultrasound scanning
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht, PD Dr
role: PRINCIPAL_INVESTIGATOR
References: