Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

Anesthesia Clinical Trial

Official title:

Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01734954
• Other study ID #: IACES
• 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

• Anesthesia

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