Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA) and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our results suggest that both continuous spinal anesthesia and combined spinal epidural anesthesia provide good surgical conditions with a low incidence of complications. The sensory block level and hemodynamic changes were lesser with CSA.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures; Knee Arthroplasty; Femur Fracture
• Intervention / Treatment: Procedure: continuous spinal anesthesia; Procedure: Spinocath a catheter for continuous spinal anesthesia; Procedure: combined spinal epidural anesthesia

Detailed Description

240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly assigned to receive either CSA or CSE. Blocks were performed in the lateral position at L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor block, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and post dural puncture headache were registered. At the end of the surgery, the catheter was removed and CSF leak was evaluated.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15015.000
      • SaoJoseRPU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fractures repair of femur, or arthroplasty of either knee or hip

Exclusion Criteria:

• Hypovolemia
• Preexisting neurologic disease
• Coagulation disorders and/or administration of thromboprophylaxis less than eight hours before the start of surgery
• Infection at the puncture site
• Agitation or delirium and the presence of a urinary bladder catheter.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSA; For CSA, an 22-G catheter (Spinocath, B.Braun Melsungen, Germany) over a 27-G Quincke needle was used. After identification of the epidural space with a Crawford needle, the catheter with the spinal needle inside was advanced through the epidural space until the dural puncture was felt and CSF was seen in the catheter. The catheter was then fed over the needle into the intrathecal space. The spinal needle and the modified Tuohy needle were removed and a luer connector and a filter previously filled with the anesthetic solution were attached to the catheter.	Procedure: continuous spinal anesthesia; bupivacaina isobaric 0.5%, 5 mg; Other Names: Major orthopedic surgeries; Procedure: Spinocath a catheter for continuous spinal anesthesia; Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric; Other Names: Catheter for continuous spinal anesthesia; Catheter for combined spinal epidural anesthesia
Experimental: CSE; CSE was performed with the "needle-through-needle" technique using a single interspace (Espocan, B.Braun Melsungen, Germany). The block consists of performing a spinal block via a 27-G spinal needle (Spinocan 125mm) introduced through an 18-G Tuohy needle (Perican 88mm) which was placed cranially directed in the epidural space. We did rotate the Tuohy needle between the spinal block and the insertion of the epidural catheter.	Procedure: Spinocath a catheter for continuous spinal anesthesia; Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric; Other Names: Catheter for continuous spinal anesthesia; Catheter for combined spinal epidural anesthesia; Procedure: combined spinal epidural anesthesia; CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany; Other Names: Catheter for continuous spinal anesthesia; Catheter for combined spinal epidural anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.	five years

Collaborators and Investigators

• Sponsor: Sao Jose do Rio Preto Medical School
• Investigators: Principal Investigator: Luiz E Imbelloni, MD, Sao Jose do Rio Preto Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): February 1, 2008
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 15, 2008
• Last Update Submitted That Met QC Criteria: February 14, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Epidural Anesthesia; Orthopedic procedures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Imbelloni&Gouveia; not applied