Completed

NCT Number: NCT01662219

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

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.

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Key information

Conditions

Cervical Disc Prolapse

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital,UHN.

Toronto, Ontario, M5T2S8, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superficial cervical plexus block for experimental group

Other

15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block

Primary outcomes

The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.

Time frame: 24 hours

Secondary outcomes

post operative pain score assessment

Time frame: 24 hours
Post operative analgesic consumption

Time frame: 24 hours
time for the first dose of opioid consumption

Time frame: 24 hrs
post operative nausea and vomiting

Time frame: 24 hrs
post operative sedation score

Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: QoR

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 10, 2012
Registry last updated: Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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