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

Comparison of two solutions of 1.5% mepivacaine with different sodium concentrations for ultrasound guided popliteal block. A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13419503

Enrollment

Registered

2015-09-04

Start date

2013-04-04

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux valgus (bunion) Musculoskeletal Diseases Hallux valgus (bunion)

Interventions

Mepivacaine, at a concentration of 1.5%, was administered for all the popliteal blocks in both groups. In the normal dilution group, the dilution was made with 1% and 2% mepivacaine. In the D5 group,

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026