A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01570491
First received: March 27, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

200 patients undergoing elective total joint arthroplasty of the lower extremity will be studied in both the ultrasound guided and the standard technique group (total sample size of N=400). Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique. A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block. The analysis will be conducted by a statistician who will be blinded.


Condition Intervention
Patients Aged 55 or Older
BMI More Than 40 kg/m2
Scoliosis
Other: ultrasound guided placement spinal block
Other: standard spinal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • number of block attempts [ Time Frame: counting, day one ] [ Designated as safety issue: No ]
    Real-time ultrasound guidance during spinal anesthesia reduces the number of attempts required for successful dural puncture.


Secondary Outcome Measures:
  • insertion depth of needle [ Time Frame: as measured in mm ] [ Designated as safety issue: No ]
    Agreement between actual needle insertion depth and the ultrasound-measured depth to the Dura.

  • compare anatomical landmark targer to ultrasound guided target for needle placement [ Time Frame: as measured in minutes before needle insertion, Day one ] [ Designated as safety issue: No ]
    Determine the correct level and compare the anatomical landmarks with the Ultrasound marks.

  • difficulty of block insertion [ Time Frame: as reported seconds after block insertion, Day one ] [ Designated as safety issue: No ]
    Difficulty of insertion, using a 10 point scale

  • block failure rate [ Time Frame: counting, Day one ] [ Designated as safety issue: No ]
    Calculate block failure rate

  • Patient satisfaction [ Time Frame: as reported minutes after injection of medication, Day one ] [ Designated as safety issue: No ]
    Record patient satisfaction

  • Incidence of PDPH (post dural puncture headache) [ Time Frame: self report minutes after injection of medication, Day one ] [ Designated as safety issue: No ]
    Incidence of PDPH (post dural puncture headache)

  • time to perform block [ Time Frame: as measured in seconds after needle insertion, Day one ] [ Designated as safety issue: No ]
    Time to perform block (from first needle insertion to injection of medication)

  • tip of needle visibility [ Time Frame: Day One ] [ Designated as safety issue: No ]
    Ability of the operator to visualize the tip of the needle with ultrasound


Estimated Enrollment: 400
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ultrasound-guided spinal anesthesia
Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.
Other: ultrasound guided placement spinal block
Anesthesiologist will use ultrasound as a guide for placement of spinal block.
Placebo Comparator: standard spinal anesthesia
Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.
Other: standard spinal anesthesia
Anesthesiologist will use standard technique for placement of spinal block.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 55 or older
  • BMI more than 40
  • Scoliosis

Exclusion criterion:

  • Patients who have undergone previous Spine Surgery
  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: NCT01570491

Contacts
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org
Contact: Ankit Maheshwari, M.D. 216-445-6500 mahesha@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Hesham Elsharkawy, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01570491     History of Changes
Other Study ID Numbers: 11-1171
Study First Received: March 27, 2012
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014