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

Cervical Disc Prolapse Clinical Trial

— QoR  

Official title:

Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662219
• Other study ID #: 12-0210-A
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: February 5, 2018
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Prolapse
• Intervertebral Disc Displacement
• Prolapse

Intervention

Other:
• Superficial cervical plexus block for experimental group
15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block

Locations

Country	Name	City	State
Canada	Toronto Western Hospital,UHN.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.		24 hours
Secondary	post operative pain score assessment		24 hours
Secondary	Post operative analgesic consumption		24 hours
Secondary	time for the first dose of opioid consumption		24 hrs
Secondary	post operative nausea and vomiting		24 hrs
Secondary	post operative sedation score		24 hrs