Stellate Ganglion Block in Head and Neck Cancer Surgery
Status: | Enrolling by invitation |
---|---|
Conditions: | Cancer, Cancer, Post-Surgical Pain |
Therapuetic Areas: | Musculoskeletal, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/9/2019 |
Start Date: | December 31, 2018 |
End Date: | November 1, 2022 |
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.
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.
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.
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.
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.
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