Clinical trial NCT01662219: Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
Official title: Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Prolapse
Keywords: superficial cervical plexus block
quality of recovery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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:

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

Primary outcomes:
measure: The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
timeFrame: 24 hours
Secondary outcomes:
measure: post operative pain score assessment
timeFrame: 24 hours
measure: Post operative analgesic consumption
timeFrame: 24 hours
measure: time for the first dose of opioid consumption
timeFrame: 24 hrs
measure: post operative nausea and vomiting
timeFrame: 24 hrs
measure: post operative sedation score
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital,UHN.
state: Ontario
Study officials:
affiliation: TWH,UHN,Toronto Canada
name: lashmikumar venkatraghavan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.