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
  Purpose

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.


Condition Intervention Phase
Scoliosis
Drug: Bupivacaine
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • VAS pain score [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Bupivacaine
Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
Other Name: Marcaine
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.
Drug: Normal Saline
Normal Saline, 4ml/hour for 72 hours.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 8 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508066

Locations
United States, California
Shriners Hospitals for Children - Los Angeles
Los Angeles, California, United States, 90020
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Study Director: Norman Otsuka, MD Shriners Hospitals for Children - Los Angeles
Principal Investigator: Anthony Scaduto, MD Shriners Hospitals for Children - Los Angeles
  More Information

No publications provided

Responsible Party: Terri Green, Clinical Data Coordinator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00508066     History of Changes
Other Study ID Numbers: SHCLA-0116
Study First Received: July 25, 2007
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Congenital Scoliosis
Idiopathic Scoliosis
Spinal Fusion
Post-Operative Pain Management
Infusion Catheter

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014