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Stellate Ganglion Block in Head and Neck Cancer Surgery

Primary Purpose

Head and Neck Cancer, Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, pain, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Augusta University Department of Otolaryngology-Head and Neck Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brief Pain Inventory
Validated pain survey in head and neck cancer patients

Secondary Outcome Measures

Inpatient morphine equivalents
Requirement of short-term post-operative narcotic therapy
Defense & Veterans Pain Rating Scale
Non-validated pain survey in head and neck cancer patients
University of Washington Quality of Life Scale Version 4 (UW-QOL 4)
Validated quality of life outcomes scale in head and neck cancer patients
EuroQol 5D-5L
Non-validated quality of life survey in head and neck cancer patients

Full Information

First Posted
October 19, 2018
Last Updated
August 25, 2023
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT03714906
Brief Title
Stellate Ganglion Block in Head and Neck Cancer Surgery
Official Title
Utility of Pre-Operative Stellate Ganglion Blockade for Pain Control in Unilateral Head and Neck Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual, lack of benefit between intervention and control arms on interim analysis
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Pain, Postoperative
Keywords
head and neck cancer, pain, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
Validated pain survey in head and neck cancer patients
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Inpatient morphine equivalents
Description
Requirement of short-term post-operative narcotic therapy
Time Frame
1-7 days or longer depending on length of stay
Title
Defense & Veterans Pain Rating Scale
Description
Non-validated pain survey in head and neck cancer patients
Time Frame
2 years
Title
University of Washington Quality of Life Scale Version 4 (UW-QOL 4)
Description
Validated quality of life outcomes scale in head and neck cancer patients
Time Frame
2 years
Title
EuroQol 5D-5L
Description
Non-validated quality of life survey in head and neck cancer patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Byrd, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University Department of Otolaryngology-Head and Neck Surgery
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29276402
Citation
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.
Results Reference
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PubMed Identifier
16318661
Citation
Wang 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.
Results Reference
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PubMed Identifier
21627622
Citation
McDonnell 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.
Results Reference
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PubMed Identifier
24849638
Citation
Jones 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.
Results Reference
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PubMed Identifier
18950449
Citation
Salvaggio 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.
Results Reference
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PubMed Identifier
25040168
Citation
Kumar 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.
Results Reference
background
PubMed Identifier
27363209
Citation
Ghai 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.
Results Reference
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Stellate Ganglion Block in Head and Neck Cancer Surgery

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