Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block - Full Text View

Sponsored by:	Sao Jose do Rio Preto University
Information provided by:	Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:	NCT00616044

Purpose

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.

Condition	Intervention
Hip Fractures Knee Arthroplasty Femur Fracture	Procedure: continuous spinal anesthesia Procedure: Spinocath a catheter for continuous spinal anesthesia Procedure: combined spinal epidural anesthesia

MedlinePlus related topics: Anesthesia Fractures Hip Injuries and Disorders Hip Replacement Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment
Official Title:	Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:

Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CSA: Experimental 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 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
CSE: Experimental 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 Procedure: combined spinal epidural anesthesia CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany

Arms

Assigned Interventions

CSA: Experimental

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

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

CSE: Experimental

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

Procedure: combined spinal epidural anesthesia

CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616044

Contacts

Contact: Luiz E Imbelloni, MD

55.21.2521-9404

dr.imbelloni@terra.com.br

Locations

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

Sponsors and Collaborators

Sao Jose do Rio Preto University

Investigators

Principal Investigator:

Luiz E Imbelloni, MD

Sao Jose do Rio Preto University

More Information

No publications provided

Responsible Party:	Hospital de Base, São José do Rio Preto, São Paulo, Brazil. ( Luiz Eduardo Imbelloni, MD. Director of Institute Regional Anesthesia, Hospital de Base, São José do Rio Preto, São Paulo, Brazil. )
Study ID Numbers:	Imbelloni&Gouveia, Not applied
Study First Received:	February 4, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616044 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Sao Jose do Rio Preto University:

Spinal Anesthesia
Epidural Anesthesia
Orthopedic procedures

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Central Nervous System Depressants

Anesthetics
Disorders of Environmental Origin
Bupivacaine
Leg Injuries

Additional relevant MeSH terms:

Fractures, Bone
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Anesthetics
Central Nervous System Depressants
Hip Injuries

Pharmacologic Actions
Hip Fractures
Femoral Fractures
Therapeutic Uses
Leg Injuries
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009