Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery (QoR)
Primary Purpose
Cervical Disc Prolapse
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Superficial cervical plexus block for experimental group
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Prolapse focused on measuring superficial cervical plexus block, quality of recovery
Eligibility Criteria
Inclusion Criteria:
- all adult patients
- aged 18-80 years
- with ASA class I - III
- undergoing anterior cervical disc surgery in supine position
Exclusion Criteria:
- In patients who are allergic to local anesthetics
- ASA- IV patients
- Lack of informed consent
- Pregnant patient
Sites / Locations
- Toronto Western Hospital,UHN.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
superficial cervical plexus block
No Block
Arm Description
superficial cervical plexus block for experimental group
no superficial cervical plexus block for the no intervention group
Outcomes
Primary Outcome Measures
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
Secondary Outcome Measures
post operative pain score assessment
Post operative analgesic consumption
time for the first dose of opioid consumption
post operative nausea and vomiting
post operative sedation score
Full Information
NCT ID
NCT01662219
First Posted
July 24, 2012
Last Updated
February 5, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01662219
Brief Title
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
Acronym
QoR
Official Title
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Prolapse
Keywords
superficial cervical plexus block, quality of recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
superficial cervical plexus block
Arm Type
Experimental
Arm Description
superficial cervical plexus block for experimental group
Arm Title
No Block
Arm Type
No Intervention
Arm Description
no superficial cervical plexus block for the no intervention group
Intervention Type
Other
Intervention Name(s)
Superficial cervical plexus block for experimental group
Intervention Description
15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
Primary Outcome Measure Information:
Title
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
post operative pain score assessment
Time Frame
24 hours
Title
Post operative analgesic consumption
Time Frame
24 hours
Title
time for the first dose of opioid consumption
Time Frame
24 hrs
Title
post operative nausea and vomiting
Time Frame
24 hrs
Title
post operative sedation score
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all adult patients
aged 18-80 years
with ASA class I - III
undergoing anterior cervical disc surgery in supine position
Exclusion Criteria:
In patients who are allergic to local anesthetics
ASA- IV patients
Lack of informed consent
Pregnant patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lashmikumar venkatraghavan, MD
Organizational Affiliation
TWH,UHN,Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital,UHN.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25869024
Citation
Mariappan R, Mehta J, Massicotte E, Nagappa M, Manninen P, Venkatraghavan L. Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):883-90. doi: 10.1007/s12630-015-0382-3. Epub 2015 Apr 14.
Results Reference
derived
Learn more about this trial
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
We'll reach out to this number within 24 hrs