Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terri Green, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00508066
First received: July 25, 2007
Last updated: January 15, 2013
Last verified: January 2013

July 25, 2007
January 15, 2013
May 2007
January 2011   (final data collection date for primary outcome measure)
VAS pain score [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
VAS pain score [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT00508066 on ClinicalTrials.gov Archive Site
Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ] [ Designated as safety issue: Yes ]
Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ]
Not Provided
Not Provided
 
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

The purpose of this study is to evaluate the effects of continuous local anesthetic delivery on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.

Constant local analgesic infusion is a relatively new modality that provides a constant supply of medication without the need for repeat injections. This method has shown encouraging results with respect to pain levels, narcotic use, faster rehabilitation and shorter hospital stay in patients undergoing laparotomies, iliac crest bone graft harvest, and sternotomies. In addition, there have not been any reported complications when used in these scenarios.

We hope to confirm better pain control, less narcotic use (i.e. PCA), fewer narcotic side effects, better response to physical therapy and earlier discharge. Which may be generalized to the spinal surgery patient population as less pain and suffering and a better overall hospital course

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Scoliosis
  • Drug: Bupivacaine
    Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
    Other Name: Marcaine
  • Drug: Normal Saline
    Normal Saline, 4ml/hour for 72 hours.
  • Experimental: Arm 1
    Subjects in arm 1 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse 0.25 - 0.5% (according to patient's weight) Bupivacaine at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.
    Intervention: Drug: Bupivacaine
  • Placebo Comparator: Arm 2
    Subjects in arm 2 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse normal saline at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical Diagnosis of Congenital Scoliosis
  • Clinical Diagnosis of Idiopathic Scoliosis
  • Anticipated Spinal Fusion Surgery

Exclusion Criteria:

  • Less than 8 years of age
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508066
SHCLA-0116
No
Terri Green, Shriners Hospitals for Children
Shriners Hospitals for Children
Not Provided
Study Director: Norman Otsuka, MD Shriners Hospitals for Children - Los Angeles
Principal Investigator: Anthony Scaduto, MD Shriners Hospitals for Children - Los Angeles
Shriners Hospitals for Children
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP