Stellate Ganglion Block in Head and Neck Cancer Surgery

NCT03714906 | Terminated DMC

• 1 other identifier: 1317655
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Pain, Postoperative

Keywords

head and neck cancer; pain; analgesia

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  Validated pain survey in head and neck cancer patients

  2 years

Secondary Outcomes (4)

• Inpatient morphine equivalents

  1-7 days or longer depending on length of stay

• Defense & Veterans Pain Rating Scale

  2 years

• University of Washington Quality of Life Scale Version 4 (UW-QOL 4)

  2 years

• EuroQol 5D-5L

  2 years

Study Arms (2)

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.

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.

Interventions

Stellate ganglion block PROCEDURE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University Department of Otolaryngology-Head and Neck Surgery

Augusta, Georgia, 30912, United States

Location

Related Publications (7)

• 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.

  PMID: 29276402 BACKGROUND

• 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.

  PMID: 16318661 BACKGROUND

• 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.

  PMID: 21627622 BACKGROUND

• 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.

  PMID: 24849638 BACKGROUND

• 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.

  PMID: 18950449 BACKGROUND

• 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.

  PMID: 25040168 BACKGROUND

• 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.

  PMID: 27363209 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• James K Byrd, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 22, 2018
• Study Start: March 22, 2019
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

US (1)