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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01734954
Other study ID # IACES
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 10, 2012
Last updated April 17, 2013
Start date April 2013
Est. completion date September 2013

Study information

Verified date April 2013
Source CES University
Contact Marta I Berrio, MD
Phone +57 301 4839308
Email martaberrio@gmail.com
Is FDA regulated No
Health authority Colombia: National Institutes of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.


Description:

Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.

- Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.

- Age: 18-70 years.

- Weight: 40-100 kg

- Taller than 140 cm.

Exclusion Criteria:

- No patient acceptance.

- Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).

- Neuropathy or myopathy affecting the lower limb.

- Psychiatric or neurological diseases that alter the evaluation of patient.

- Arrhythmias.

- Heart failure.

- Diabetes Mellitus.

- Pregnancy.

- Language barriers.

- Anticoagulation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Sciatic nerve anesthesia blockade at bifurcation.
A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.
Sciatic nerve blockade 2 cm beyond the bifurcation
A proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.
Drug:
Levobupivacaine 0.5%: 20 ml
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Device:
Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA
An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Drug:
supplemental oxygen
supplemental oxygen during the block and/or during surgery
Midazolam
Intravenous midazolam for sedation during the block and/or during surgery
Intravenous analgesics
Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
Procedure:
Saphenous nerve block
Depending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).

Locations

Country Name City State
Colombia Clínica CES Medellín Antioquia
Colombia Hospital Pablo Tobón Uribe Medellín Antioquia

Sponsors (3)

Lead Sponsor Collaborator
CES University Clínica CES, Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Latency period of sciatic nerve block. Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes. 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block. No
Secondary Success of sciatic nerve block The time to achieve a complete sensory nerve block, reached maximum at 30 minutes, in full distribution of tibial nerve and common fibular nerve for anesthesia. Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery. No
Secondary Patient satisfaction Using a categorical score we will measure satisfaction of nerve-block-procedure satisfaction and analgesia quality one day after surgery: patients will choose one of three options: no satisfied, satisfied or very satisfied. Postoperative 24 hours No
Secondary Sensory block Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves
0: Complete sensory block
Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle
Feeling normal (for each component: tibial and common peroneal) compared with the contralateral leg
5, 10, 15, 20, 25 and 30 minutes after the block is finished No
Secondary Motor block Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves 0: Complete motor blockade
Motor block almost complete
No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg
5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished No
Secondary First analgesic Time of first analgesic requirement in postoperative 5 minutes, 30 minutes, 24 hours postoperative No
Secondary Visual analog scale at rest Pain rating ranging from zero to ten VAS 0: no pain VAS 1-3: Mild pain VAS 4-6: Moderate Pain VAS 7-10: Severe pain 5 minutes, 30 minutes, 24 hours postoperative No
Secondary Dynamic visual analog scale Pain rating ranging from zero to ten with the movement 5 minutes, 30 minutes, 24 hours postoperative No
Secondary Intraneural injection Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection At the time of injection and execution of the block Yes
Secondary Vascular puncture Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block During the execution of the block Yes
Secondary Paresthesia during the procedure Paresthesia during the procedure At the time of the execution of the block Yes
Secondary Systemic toxicity of local anesthetics Systemic toxicity of local anesthetics During the execution of the block and 30 minutes after it Yes
Secondary Hematoma Hematoma During and inmmediately after the execution of the block Yes
Secondary Muscle weakness Subjective reduction in muscle strength at 24 hours postoperative 24 hours postoperative Yes
Secondary Altered sensitivity Subjective decreased sensitivity at 24 hours postoperative 24 hours postoperative Yes
Secondary Cramps postoperative Feeling cramps within 24 hours of the block 24 hours postoperative of the block Yes
Secondary Punctures Number of skin punctures during the block During the block No
Secondary Time for the execution of nerve block Time from placement of the transducer for the initial scan to final withdrawal of the needle In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle No
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