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
  Purpose

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.


Condition Intervention
Cervical Disc Prolapse
Other: Superficial cervical plexus block for experimental group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: superficial cervical plexus block
superficial cervical plexus block for experimental group
Other: Superficial cervical plexus block for experimental group
15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
No Intervention: No Block
no superficial cervical plexus block for the no intervention group

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)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  1. In patients who are allergic to local anesthetics
  2. ASA- IV patients
  3. Lack of informed consent
  4. Pregnant patient
  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: NCT01662219

Locations
Canada, Ontario
Toronto Western Hospital,UHN.
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: lashmikumar venkatraghavan, MD TWH,UHN,Toronto Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01662219     History of Changes
Other Study ID Numbers: 12-0210-A
Study First Received: July 24, 2012
Last Updated: August 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
superficial cervical plexus block
quality of recovery

Additional relevant MeSH terms:
Prolapse
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia

ClinicalTrials.gov processed this record on August 20, 2014