Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery (QoR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01662219
First received: July 24, 2012
Last updated: August 18, 2014
Last verified: June 2014

July 24, 2012
August 18, 2014
August 2012
June 2014   (final data collection date for primary outcome measure)
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01662219 on ClinicalTrials.gov Archive Site
  • post operative pain score assessment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Post operative analgesic consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • time for the first dose of opioid consumption [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • post operative nausea and vomiting [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • post operative sedation score [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion

Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted as moderate in severity, often needing oral opioid analgesics. In addition, these patients are more prone for postoperative respiratory complication due to airway edema secondary to surgical retraction or wound hematoma. Opioid analgesics provide good pain control but postoperative nausea and vomiting and respiratory depression are undesirable in these patients who are at risk for postoperative wound hematoma and airway edema The use of multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after ambulatory procedures at most surgery centers throughout the world . The purpose of this study is to determine whether superficial cervical plexus block will improve the postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.

Anterior cervical discectomy and fusion is increasingly being done as a day surgery or short stay surgery. Postoperative pain is the leading cause of unplanned hospital admissions following day surgery, a major source of dissatisfaction and often impairs the quality of recovery. Opioid analgesics alone are not always effective and may also worsen the postoperative nausea and vomiting and in turn the postoperative recovery. This study is designed to find out if an injection of freezing on the side of neck around the nerves (superficial cervical plexus block) improves the quality of recovery from anesthesia and surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery.

Primary Outcome Measure The primary outcome measure is the global QoR-40 aggregate score at 24 hours after surgery.

Secondary Outcome Measures

  • Postoperative pain scores (first 24 hours)
  • Total analgesic consumption (first 24 hours)
  • Time for first opioid administration
  • Postop Nausea and vomiting (first 24 hours)
  • Post operative sedation (first 24 hours)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Disc Prolapse
Other: Superficial cervical plexus block for experimental group
15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
  • Experimental: superficial cervical plexus block
    superficial cervical plexus block for experimental group
    Intervention: Other: Superficial cervical plexus block for experimental group
  • No Intervention: No Block
    no superficial cervical plexus block for the no intervention group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all adult patients
  • aged 18-80 years
  • with ASA class I - III
  • undergoing anterior cervical disc surgery in supine position

Exclusion Criteria:

  1. In patients who are allergic to local anesthetics
  2. ASA- IV patients
  3. Lack of informed consent
  4. Pregnant patient
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01662219
12-0210-A
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: lashmikumar venkatraghavan, MD TWH,UHN,Toronto Canada
University Health Network, Toronto
June 2014

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