Cervical Disc ProlapseQoRNCT01662219
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
A study testing Superficial cervical plexus block for experimental group in people with Cervical Disc Prolapse, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Disc Prolapse
- What is being tested?
- Superficial cervical plexus block for experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adult patients
- aged 18-80 years
- with ASA class I - III
- undergoing anterior cervical disc surgery in supine position
Who cannot join
- In patients who are allergic to local anesthetics
- ASA- IV patients
- Lack of informed consent
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion
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.
Read the 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)
- Conditions
- Cervical Disc Prolapse
- Being tested
- Superficial cervical plexus block for experimental group
- Keywords
- superficial cervical plexus block, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical plexus block for experimental groupOther
15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
| Study group | Role | What they receive |
|---|---|---|
| superficial cervical plexus block | Experimental | superficial cervical plexus block for experimental group Receives: Other: Superficial cervical plexus block for experimental group |
| No Block | No intervention | no superficial cervical plexus block for the no intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
Measured: 24 hours
Secondary outcomes (5)
post operative pain score assessment
Measured: 24 hours
Post operative analgesic consumption
Measured: 24 hours
time for the first dose of opioid consumption
Measured: 24 hrs
post operative nausea and vomiting
Measured: 24 hrs
post operative sedation score
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc ProlapseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- lashmikumar venkatraghavan, MD, Principal investigator, TWH,UHN,Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662219
- Sponsor's protocol ID
- 12-0210-A
- Acronym
- QoR
- Status last verified
- Feb 2018
- First submitted
- 24 Jul 2012
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25869024
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion
- ClinicalTrials.gov ID
- NCT01662219
- Acronym / sponsor ID
- QoR / 12-0210-A
- Conditions
- Cervical Disc Prolapse
- Keywords
- superficial cervical plexus block, quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superficial cervical plexus block | Experimental | Other: Superficial cervical plexus block for experimental groupsuperficial cervical plexus block for experimental group |
| No Block | No intervention | –no superficial cervical plexus block for the no intervention group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- all adult patients
- aged 18-80 years
- with ASA class I - III
- undergoing anterior cervical disc surgery in supine position
Key exclusion criteria (4 listed)
- In patients who are allergic to local anesthetics
- ASA- IV patients
- Lack of informed consent
- Pregnant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial cervical plexus block for experimental group15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block | Other | superficial cervical plexus block |
Primary outcome
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
Time frame: 24 hours
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Derived from this study: PubMed 25869024Mariappan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lashmikumar venkatraghavan, MD principal investigator
TWH,UHN,Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical plexus block for experimental group in people with Cervical Disc Prolapse, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.