Stellate Ganglion Block in Head and Neck Cancer Surgery
关键词
抽象
描述
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.
日期
最后验证: | 12/31/2019 |
首次提交: | 10/18/2018 |
提交的预估入学人数: | 10/18/2018 |
首次发布: | 10/21/2018 |
上次提交的更新: | 01/07/2020 |
最近更新发布: | 01/09/2020 |
实际学习开始日期: | 03/21/2019 |
预计主要完成日期: | 10/31/2020 |
预计完成日期: | 10/31/2022 |
状况或疾病
干预/治疗
Procedure: Treatment
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Treatment 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: Treatment 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. |
No Intervention: Control 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. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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. |
结果
主要结果指标
1. Brief Pain Inventory [2 years]
次要成果指标
1. Inpatient morphine equivalents [1-7 days or longer depending on length of stay]
2. Defense & Veterans Pain Rating Scale [2 years]
3. University of Washington Quality of Life Scale Version 4 (UW-QOL 4) [2 years]
4. EuroQol 5D-5L [2 years]