Head and Neck CancerNCT03714906
Stellate Ganglion Block in Head and Neck Cancer Surgery
A study testing Stellate ganglion block in people with Head and Neck Cancer and Pain, Postoperative, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with unilateral surgery. In this study, patients will be randomly assigned to receive either pre-operative stellate ganglion block or no pre-operative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pain, Postoperative
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 15 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking patients who are greater than eighteen years of age with a known diagnosis of head and neck cancer and are planned to undergo surgery with unilateral neck dissection will be eligible for this study
Who cannot join
- Patients with a history of preoperative narcotic use for conditions unrelated to their head and neck cancer will be excluded.
- Patients younger than eighteen years of age, patients with a history of vocal cord paralysis on the non-surgical side, patients with a history of severe difficulty swallowing, and pregnant patients will be excluded from this study.
- Patients with a history of abnormal heart rhythm will be considered to have a relative contraindication and will require clearance by the consultant anesthesiologist prior to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University Department of Otolaryngology-Head and Neck Surgery
Augusta, Georgia, 30912
About this study
Official title: Utility of Pre-Operative Stellate Ganglion Blockade for Pain Control in Unilateral Head and Neck Cancer Surgery
The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with unilateral surgery. In this study, patients will be randomly assigned to receive either pre-operative stellate ganglion block or no pre-operative treatment. Blocks will be placed by a trained anesthesiologist using ultrasound guidance in the preoperative holding area prior to surgery. All patients will receive the same post-operative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.
Read the detailed description
Sympathetic blockade of the stellate ganglion is used for upper limb, temporomandibular joint, and facial pain, and may be placed pre-operatively to decrease post-operative pain in upper limb orthopedic surgery. Use of this block for head and neck cancer pain has been studied with mixed results in a case series in the distant past prior to the advent of image guidance or newer long-lasting anesthetic drugs. One recent case report for intractable head and neck cancer pain demonstrated encouraging results with relief provided after diagnostic stellate ganglion blockade followed by chemical neurolysis.
Patients who choose to participate in the study will be randomly assigned to receive either stellate ganglion block placement in the pre-operative holding area on the day of surgery or no pre-operative intervention. Participating patients will be asked to fill out separate questionnaires to evaluate pain and quality of life preoperatively and post-operatively.
Upon enrollment in the study, patients will be assigned an identification number and will undergo simple randomization to either the control or treatment group using a randomly computer-generated sequence. If patients have not had an evaluation of vocal cord mobility on prior workup, this will be assessed by flexible fiberoptic laryngoscopy prior to proceeding with block placement.
Patients assigned to receive a block will have it placed on the respective surgical side in the pre-operative holding area on the day of surgery. A trained anesthesiologist will perform the placement using an injection of 0.25% bupivacaine under ultrasound guidance. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Surveys will be administered and collected on a daily basis while patients are in the hospital. If patients are already utilizing other non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic pain medications (Neurontin), they will be allowed to continue these medications while inpatient provided there are no changes in dosing. Home non-steroidal anti-inflammatory analgesic medications will be withheld while patients are in the hospital due to the potential risk of post-operative bleeding and kidney injury related to use of these medications in the perioperative setting. These medications may be resumed once you are discharged from the hospital.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow up. Follow up visits will occur one week after discharge, four weeks after discharge, and then every three months until completion of the two year study period.
- Conditions
- Head and Neck Cancer, Pain, Postoperative
- Being tested
- Stellate ganglion block
- Keywords
- head and neck cancer, pain, analgesia
- Medical subject headings
- Head and Neck Neoplasms, Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
Stellate ganglion block will consist of an injection of 0.25% bupivacaine placed under ultrasound guidance by a trained anesthesiologist in the pre-operative holding area prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients randomized to the Treatment arm will be assigned to receive a stellate ganglion block. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of post-operative pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Receives: Procedure: Stellate ganglion block |
| Control | No intervention | Patients assigned to the Control arm will receive no pre-operative intervention. While in the hospital after surgery, these patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of post-operative pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Validated pain survey in head and neck cancer patients
Measured: 2 years
Secondary outcomes (4)
Inpatient morphine equivalents
Requirement of short-term post-operative narcotic therapy
Measured: 1-7 days or longer depending on length of stay
Defense & Veterans Pain Rating Scale
Non-validated pain survey in head and neck cancer patients
Measured: 2 years
University of Washington Quality of Life Scale Version 4 (UW-QOL 4)
Validated quality of life outcomes scale in head and neck cancer patients
Measured: 2 years
EuroQol 5D-5L
Non-validated quality of life survey in head and neck cancer patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start22 Mar 2019
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Why it stopped: Slow accrual, lack of benefit between intervention and control arms on interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K Byrd, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714906
- Sponsor's protocol ID
- 1317655
- Status last verified
- Aug 2023
- First submitted
- 19 Oct 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.
PubMed 29276402Wang QX, Wang XY, Fu NA, Liu JY, Yao SL. Stellate ganglion block inhibits formalin-induced nociceptive responses: mechanism of action. Eur J Anaesthesiol. 2005 Dec;22(12):913-8. doi: 10.1017/S0265021505001559.
PubMed 16318661McDonnell JG, Finnerty O, Laffey JG. Stellate ganglion blockade for analgesia following upper limb surgery. Anaesthesia. 2011 Jul;66(7):611-4. doi: 10.1111/j.1365-2044.2011.06626.x. Epub 2011 May 31.
PubMed 21627622Jones GP, Tripathi SS. Successful use of stellate ganglion block and a new centrally acting analgesic with dual mode of action in a resistant temporomandibular joint pain. BMJ Case Rep. 2014 May 20;2014:bcr2013203308. doi: 10.1136/bcr-2013-203308.
PubMed 24849638Salvaggio I, Adducci E, Dell'Aquila L, Rinaldi S, Marini M, Zappia L, Mascaro A. Facial pain: a possible therapy with stellate ganglion block. Pain Med. 2008 Oct;9(7):958-62. doi: 10.1111/j.1526-4637.2008.00515.x.
PubMed 18950449Kumar N, Thapa D, Gombar S, Ahuja V, Gupta R. Analgesic efficacy of pre-operative stellate ganglion block on postoperative pain relief: a randomised controlled trial. Anaesthesia. 2014 Sep;69(9):954-660. doi: 10.1111/anae.12774. Epub 2014 Jul 7.
PubMed 25040168Ghai A, Kaushik T, Kumar R, Wadhera S. Chemical ablation of stellate ganglion for head and neck cancer pain. Acta Anaesthesiol Belg. 2016;67(1):6-8.
PubMed 27363209
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pre-Operative Stellate Ganglion Blockade for Pain Control in Unilateral Head and Neck Cancer Surgery
- ClinicalTrials.gov ID
- NCT03714906
- Acronym / sponsor ID
- 1317655
- Conditions
- Head and Neck Cancer, Pain, Postoperative
- Keywords
- head and neck cancer, pain, analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual, lack of benefit between intervention and control arms on interim analysis
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with unilateral surgery. In this study, patients will be randomly assigned to receive either pre-operative stellate ganglion block or no pre-operative treatment. Blocks will be placed by a trained anesthesiologist using ultrasound guidance in the preoperative holding area prior to surgery. All patients will receive the same post-operative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.
Detailed description
Sympathetic blockade of the stellate ganglion is used for upper limb, temporomandibular joint, and facial pain, and may be placed pre-operatively to decrease post-operative pain in upper limb orthopedic surgery. Use of this block for head and neck cancer pain has been studied with mixed results in a case series in the distant past prior to the advent of image guidance or newer long-lasting anesthetic drugs. One recent case report for intractable head and neck cancer pain demonstrated encouraging results with relief provided after diagnostic stellate ganglion blockade followed by chemical neurolysis.
Patients who choose to participate in the study will be randomly assigned to receive either stellate ganglion block placement in the pre-operative holding area on the day of surgery or no pre-operative intervention. Participating patients will be asked to fill out separate questionnaires to evaluate pain and quality of life preoperatively and post-operatively.
Upon enrollment in the study, patients will be assigned an identification number and will undergo simple randomization to either the control or treatment group using a randomly computer-generated sequence. If patients have not had an evaluation of vocal cord mobility on prior workup, this will be assessed by flexible fiberoptic laryngoscopy prior to proceeding with block placement.
Patients assigned to receive a block will have it placed on the respective surgical side in the pre-operative holding area on the day of surgery. A trained anesthesiologist will perform the placement using an injection of 0.25% bupivacaine under ultrasound guidance. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Surveys will be administered and collected on a daily basis while patients are in the hospital. If patients are already utilizing other non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic pain medications (Neurontin), they will be allowed to continue these medications while inpatient provided there are no changes in dosing. Home non-steroidal anti-inflammatory analgesic medications will be withheld while patients are in the hospital due to the potential risk of post-operative bleeding and kidney injury related to use of these medications in the perioperative setting. These medications may be resumed once you are discharged from the hospital.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow up. Follow up visits will occur one week after discharge, four weeks after discharge, and then every three months until completion of the two year study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Stellate ganglion blockPatients randomized to the Treatment arm will be assigned to receive a stellate ganglion block. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of post-operative pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. |
| Control | No intervention | –Patients assigned to the Control arm will receive no pre-operative intervention. While in the hospital after surgery, these patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of post-operative pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking patients who are greater than eighteen years of age with a known diagnosis of head and neck cancer and are planned to undergo surgery with unilateral neck dissection will be eligible for this study
Key exclusion criteria (3 listed)
- Patients with a history of preoperative narcotic use for conditions unrelated to their head and neck cancer will be excluded.
- Patients younger than eighteen years of age, patients with a history of vocal cord paralysis on the non-surgical side, patients with a history of severe difficulty swallowing, and pregnant patients will be excluded from this study.
- Patients with a history of abnormal heart rhythm will be considered to have a relative contraindication and will require clearance by the consultant anesthesiologist prior to participation in the study.
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 |
|---|---|---|
| Stellate ganglion blockStellate ganglion block will consist of an injection of 0.25% bupivacaine placed under ultrasound guidance by a trained anesthesiologist in the pre-operative holding area prior to surgery. | Procedure or surgery | Treatment |
Primary outcome
Brief Pain Inventory
Time frame: 2 years
Validated pain survey in head and neck cancer patients
4 secondary outcomes
Inpatient morphine equivalents
Time frame: 1-7 days or longer depending on length of stay
Defense & Veterans Pain Rating Scale
Time frame: 2 years
University of Washington Quality of Life Scale Version 4 (UW-QOL 4)
Time frame: 2 years
EuroQol 5D-5L
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow accrual, lack of benefit between intervention and control arms on interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 29276402Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.
- Background: PubMed 16318661Wang QX, Wang XY, Fu NA, Liu JY, Yao SL. Stellate ganglion block inhibits formalin-induced nociceptive responses: mechanism of action. Eur J Anaesthesiol. 2005 Dec;22(12):913-8. doi: 10.1017/S0265021505001559.
- Background: PubMed 21627622McDonnell JG, Finnerty O, Laffey JG. Stellate ganglion blockade for analgesia following upper limb surgery. Anaesthesia. 2011 Jul;66(7):611-4. doi: 10.1111/j.1365-2044.2011.06626.x. Epub 2011 May 31.
- Background: PubMed 24849638Jones GP, Tripathi SS. Successful use of stellate ganglion block and a new centrally acting analgesic with dual mode of action in a resistant temporomandibular joint pain. BMJ Case Rep. 2014 May 20;2014:bcr2013203308. doi: 10.1136/bcr-2013-203308.
- Background: PubMed 18950449Salvaggio I, Adducci E, Dell'Aquila L, Rinaldi S, Marini M, Zappia L, Mascaro A. Facial pain: a possible therapy with stellate ganglion block. Pain Med. 2008 Oct;9(7):958-62. doi: 10.1111/j.1526-4637.2008.00515.x.
- Background: PubMed 25040168Kumar N, Thapa D, Gombar S, Ahuja V, Gupta R. Analgesic efficacy of pre-operative stellate ganglion block on postoperative pain relief: a randomised controlled trial. Anaesthesia. 2014 Sep;69(9):954-660. doi: 10.1111/anae.12774. Epub 2014 Jul 7.
- Background: PubMed 27363209Ghai A, Kaushik T, Kumar R, Wadhera S. Chemical ablation of stellate ganglion for head and neck cancer pain. Acta Anaesthesiol Belg. 2016;67(1):6-8.
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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.
James K Byrd, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Head and Neck Cancer and Pain, Postoperative, run by Augusta University at 1 site in United States.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Aug 2023. 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 United States. 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 was stopped early (reason given: Slow accrual, lack of benefit between intervention and control arms on interim analysis). Results are not available in the source record.
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?
Brief Pain Inventory (time frame: 2 years). 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 NCT03714906, which also lists 7 linked publications.
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 29 Aug 2023.