Effect of Superficial Cervical Plexus Block on the Postop... | NCT01662219

Studies
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery

NCT01662219

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Feb 6, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Cervical Disc Prolapse

Interventions

Superficial cervical plexus block for experimental group

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 24, 2012

First Submission Date that Met QC Criteria

Aug 7, 2012

First Posted Date

Aug 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2018

Last Update Posted Date

Feb 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lashmi Venkatraghavan, Dr. Lashmikumar Venkatraghavan, Asst. Professor,Dept. of Anesthesia, TWH, UHN,Toronto,ON., University Health Network, TorontoPrincipal Investigator

Lead Sponsor

University Health Network, TorontoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
superficial cervical plexus block	Experimental	superficial cervical plexus block for experimental group	Other: Superficial cervical plexus block for experimental group
No Block	No Intervention	no superficial cervical plexus block for the no intervention group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Superficial cervical plexus block for experimental group	Other	15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block	superficial cervical plexus block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.		24 hours

Secondary Outcomes

Measure	Description	Time Frame
post operative pain score assessment		24 hours
Post operative analgesic consumption		24 hours
time for the first dose of opioid consumption

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
lashmikumar venkatraghavan, MD	TWH,UHN,Toronto Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital,UHN.		Toronto	Ontario	M5T2S8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25869024	Derived	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.