Skip to content

Supramalleolar anesthetic approach does not improve tibial nerve block success rates: a randomized trial in 110 participants.

Supramalleolar anesthetic approach does not improve tibial nerve block success rates: a randomized trial in 110 participants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12176047
Enrollment
110
Registered
2019-08-20
Start date
2016-11-15
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Foot anesthesia Surgery

Interventions

The study sample comprised 110 subjects, who were assigned at random to the two study groups. A simple randomized list (allocation sequence) with numeric sequential unique identifiers was produced by
n=55) received a retromalleolar tibial nerve block. The second group (SMB
n=55) received a supramalleolar tibial nerve block. All the anesthetic blocks were administered by the same person, the principal researcher. The variables were analyzed and tested by an external obse

Sponsors

Department of Nursing, Universitat de València
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years 2. Classified as ASA I or II, 3. Require anesthetic blocking of the tibial nerve

Exclusion criteria

Exclusion criteria: 1. Non-palpable peripheral pulses and/or an ankle edema, making it impossible to locate the anatomical reference points 2. Coagulation disorders and/or infections at the target injection sites 3. Record of allergies to amide-type local anesthetics 4. Pregnancy or lactation 5. Neurological or neuromuscular diseases 6. Chronic analgesic treatment with opiate derivatives 7. Cognitive impairment

Design outcomes

Primary

MeasureTime frame
1. Extent of nerve blocking assessed using the number of areas with an absence of pain sensitivity (pin-prick test with 21G needle) and thermal sensitivity (swab soaked in alcohol). For this purpose, the tibial nerve dermatome was divided into three areas. A1 was the region innervated by the calcaneal nerve, A2 the region innervated by the medial plantar nerve and A3 the region innervated by the lateral plantar nerve. Both sensitivity tests were conducted at 5-min intervals, starting 5 min after injection of the local anesthetic and ending on reaching the absolute latency time or 30 min after the blocking injection. The tibial nerve blocking result, measured 30 min after initiating the block, was considered a failed block if the patient presented pain in the pin-prick test or sensitivity to cold in each of the three areas into which the tibial nerve dermatome was divided; an incomplete block if the patient only felt pain or cold in one or two of the areas; or an effective block if pain on pin-pricking and sensation of coldness were absent from all three areas.

Secondary

MeasureTime frame
1. Presence of vascular and/or peri/intraneural puncture during the procedure. 2. Relative latency time (time in s from inserting the needle until the patient showed the first symptoms of anesthesia) 3. Absolute latency time (time in s between inserting the needle and a complete absence of pain and thermal sensitivity in the sole of the foot) 4. Anesthetic blocking duration (time in hours between attaining blocking and the first appearance of paresthesias in the sole of the foot) 5. Patient’s level of pain during puncture assessed on a 10-point visual analog scale (VAS). VAS scores of 0–3 were considered low pain, 4–6 moderate pain and 7–10 intense pain. 6. Need for intraoperative anesthetic reinforcement measured by the number of patients who had attained effective blocking of the tibial nerve but required additional local anesthetic during surgery. It was classed as 1 when the patient needed an additional deposit of local anesthetic during the surgical procedure. All secondary outcomes were measured starting once the anesthetic block was achieved until the anesthetic block was completed. All the anesthetic blocks were administered by the same person. The variables were analyzed and tested by an external observer who recorded the results achieved in an anesthetic process record sheet. The data obtained were reviewed and analyzed once the study sample was achieved, with IBM SPSSv22 software.

Countries

Spain

Outcome results

None listed

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