Stellate Ganglion Block in Head and Neck Cancer Surgery
- Conditions
- Head and Neck CancerPain, Postoperative
- Interventions
- Procedure: Stellate ganglion block
- Registration Number
- NCT03714906
- Lead Sponsor
- Augusta University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Stellate ganglion block 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.
- Primary Outcome Measures
Name Time Method Brief Pain Inventory 2 years Validated pain survey in head and neck cancer patients
- Secondary Outcome Measures
Name Time Method Inpatient morphine equivalents 1-7 days or longer depending on length of stay Requirement of short-term post-operative narcotic therapy
Defense & Veterans Pain Rating Scale 2 years Non-validated pain survey in head and neck cancer patients
University of Washington Quality of Life Scale Version 4 (UW-QOL 4) 2 years Validated quality of life outcomes scale in head and neck cancer patients
EuroQol 5D-5L 2 years Non-validated quality of life survey in head and neck cancer patients
Trial Locations
- Locations (1)
Augusta University Department of Otolaryngology-Head and Neck Surgery
🇺🇸Augusta, Georgia, United States