Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery (QoR)
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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 |
- The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 46 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (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 |
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
Contacts and Locations| Contact: Lashmikumar venkatraghavan, MD | 416-603 ext 5800 | Lashmi.Venkatraghavan@uhn.ca |
| Canada, Ontario | |
| Toronto Western Hospital,UHN. | Not yet recruiting |
| Toronto, Ontario, Canada, M5T2S8 | |
| Contact: Lashmi kumar venkatraghavan, MD 416-603 ext 5800 Lashmi.Venkatraghavan@uhn.ca | |
| Contact: Pirjo Manninen, MD Pirjo.Manninen@uhn.ca | |
| Sub-Investigator: Ramamani Mariappan, MD | |
| Sub-Investigator: Pirjo Manninen, MD | |
| Sub-Investigator: Eric Massicotte, MD | |
| 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 7, 2012 |
| 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 Disk Displacement Pathological Conditions, Anatomical Spinal Diseases |
Bone Diseases Musculoskeletal Diseases Hernia |
ClinicalTrials.gov processed this record on June 18, 2013