Efficacy of two local anaesthetic preparations with different sodium content, in sciatic nerve block for hallux valgus (bunion) surgery

Completed

Conditions: Hallux valgus (bunion)
Musculoskeletal Diseases

Registration Number: ISRCTN13419503

Lead Sponsor: a Paz University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 66

Inclusion Criteria

1. Patients scheduled for unilateral hallux valgus surgery repair by osteotomy of the first metatarsal type chevron, and intended to be operated by the same surgical team
2. Age between 18 and 80 years
3. Physical status ASA I-III
4. Body mass index (BMI) less than 35 kg / m2

Exclusion Criteria

1. Existence of any regional anaesthesia contraindication
2. Inability to distinguish the popliteal nerve with ultrasound
3. Cognitive impairment
4. Chronic use of opioids and/or neuroleptic drugs
5. Pregnancy
6. Peripheral neuropathy
7. Patients less than 18 years old or more than 80
8. ASA IV classification
9. Allergy to drugs used in the study
10. Body mass index (BMI) = 35 kg/m2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete sensory blockade in popliteal territory after 30 minutes of the puncture (YES/NO). With the sequence of complete and incomplete blockades the effective dose is calculated in 50% of patients (ED50) of 1.5% mepivacaine that provides complete sensory ultrasound-guided block of the sciatic nerve with a popliteal approach in both groups, following the up-and-down allocation technique described by Dixon.

Secondary Outcome Measures

Name	Time	Method
1. ED90 and ED95 of 1.5% mepivacaine in both groups<br>2. Need for an extra dose of local anaesthetic through the catheter before or during surgery (YES/NO)<br>3. Need for sedation (YES/NO) and/or general anaesthesia (YES/NO) during surgery<br>4. Presence of any adverse events related to the puncture (YES/NO). If yes, note what kind of event<br>5. Time to recover the normal sensation and movement of the foot (it was asked to the patient 24 hours after the puncture)<br>6. Patient satisfaction (on a scale from 1 to 10) at 24 hours after the puncture<br>7. Existence of paraesthesias, sensory, or motor deficit in the foot at 24, 48 hours and 1 week after the puncture