NCT01734954

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
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.
PROCEDURE	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.
DEVICE	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
DRUG	Midazolam	Intravenous midazolam for sedation during the block and/or during surgery
DRUG	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).

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-11-28
• Last updated: 2013-04-19

Locations

2 sites across 1 country: Colombia