Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Antipyretics

Anti-Inflammatory Agents

Antitussive Agents

Respiratory System Agents

Anesthetics

Bupivacaine

Fentanyl

Oxycodone

Acetaminophen

Ropivacaine

Morphine

Hydromorphone

Anesthetics, Local

Analgesics, Opioid

Anesthetics, General

Codeine

Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Ultrasound-guided erector spinae plane block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Paravertebral block

Ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Erector spinae plane block

General anesthesia administered as per preference of intra-operative attending anesthesiologist

General anesthetic

Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone. Post-operatively in post anesthesia care unit, morphine and hydromorphone will be titrated to effect as necessary. After discharge from post anesthesia care unit, oral analgesia will be administered on an as required basis e.g. acetaminophen, non-steroid anti-inflammatory medications, acetaminophen / codeine and acetaminophen / oxycodone.

Opioids

Weight-based dosing of this local anesthetic mixture.

This study aims to compare the effectiveness of paravertebral block and erector spinae plane block after mastectomy.

The primary objective of this randomized controlled trial is to demonstrate equivalent dermatomal spread for ultrasound-guided single-injection Erector Spinae Plane (ESP) block performed at T4-T5 level and ultrasound-guided single-injection (paravertebral) PVB block at the same level.

Secondary objectives are Numerical Rating Scale (NRS) pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion.

The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform with less associated discomfort during block insertion.

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgery. Advantages of a PVB technique include reduced postoperative pain, analgesic consumption, opioid-related side effects, and shorter post anesthesia care unit (PACU) stay. There is also evidence to suggest that PVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura. Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. Radiological imaging in a cadaver model has demonstrated that a single injection at the level of the T5 transverse process produced cranio-caudal spread between C7 and T8. This accounts for the extensive sensory block that has been observed in case reports and is at least as extensive as the spread seen with PVB.

ESP is a more superficial block with a better defined end-point - injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. Furthermore, ESP does not have the same risk of pneumothorax as PVB.There have been no randomized controlled trials involving ESP to date. All descriptions of the technique have been in case report / series format.

The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform, has less associated discomfort and fewer complication risks.

All eligible participants will be randomized to the PVB arm or the ESP arm after fully informed consent has been obtained. Subjects randomized to the PVB arm will have an ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Subjects randomized to the ESP arm will have an ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Conduct of intra-operative anesthesia will be at the discretion of the attending anesthesiologist.

The primary outcome is equivalent dermatomal spread for ultrasound-guided single-injection ESP block performed at T4-T5 level and ultrasound-guided single-injection PVB block at the same level.

Secondary outcomes are NRS pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion.

The primary outcome will be collected by a research associate who is blinded to the study group allocation. The secondary outcomes will be collected by the study team from the patient chart and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test. Markers of intervention safety will be monitored included local anesthetic toxicity, nerve injury, infection and pneumothorax.

A test of equivalence will be performed for the primary outcome of dermatomal spread between the 2 groups. If the equivalence is not established for the block extent, a 2-way superiority will be conducted. Secondary outcomes will be analyzed using Mann-Whitney U test and the Hodges-Lehmann method for calculating 95% confidence intervals (CIs) around the median difference. Assuming a median difference of 1.5 dermatomal segments, and a pooled standard deviation (SD) of 1.65 segments, α of 0.05, and 90% power, a total sample size of 42 patients is estimated (21 patients in each group).

Erector Spinae Plane Block Versus Paravertebral Block

Erector Spinae Plane Block Versus Paravertebral Block in Patients Undergoing Elective Breast Surgery. A Randomized Controlled Trial Comparing Dermatomal Spread.

Assessment of extent of sensory block by pinprick

Subjective pain score between 0 (no pain) and 10 (worst possible pain) immediately post-operatively at 6, 12 and 24 hours

Amount of opioid administered by the intra-operative anesthesiologist

Amount of opioid used by patient in the first 24 hours after surgery

Amount of time it takes to perform the block procedure starting with when the ultrasound image is acquired and finishing when all of the local anesthetic has been injected

University of Alberta

Rare Diseases

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Anti-Arrhythmia Agents

Channel Blockers

Anticonvulsants

Reproductive Control Agents

Antihypertensive Agents

Vasodilator Agents

Vasoconstrictor Agents

Dexmedetomidine

Magnesium Sulfate

Propranolol

Angiotensin Receptor Antagonists

Labetalol

Angiotensin II

Giapreza

Angiotensinogen

Adrenergic Agents

Adrenergic Antagonists

Ramipril

Prazosin

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

Bisoprolol

Candesartan

Candesartan cilexetil

Atenolol

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Traditional group in which the patients̕ hemodynamic adjustment will be conducted using orally or IV α₁ \& β-adrenergic blockers \[Prazosin (minipress): 0.5-20 mg/day, Propranolol (Inderal) :10-360 mg/day, Bisoprolol (Concor): 2.5-20 mg/day, Atenolol (Tenormin): 25-100 mg/day \&/or Labetalol (Trandate)200-600 mg/day, Angiotensin Converting enzyme inhibitors ( ACE inhibitors ) \& Angiotensin II receptor blockers ARBs e.g. Tritace 2.5-10 mg/day \& Atacand 4-16 mg/day\]

Dexmedetomidine-Magnesium Sulfate (Dex-MgSo₄) group: in which in addition to the orally prescribed drugs; on admission to the ICU, the Pheo-patient has serum-Mg level measurement \& a bolus of 40 mg/kg MgSo₄ is given I.V. \& may be repeated until the therapeutic level of MgSo₄ 2-4 mmol/Liter is reached. Dexmedetomidine sedation is started the evening prior to surgery by loading dose of 1µg/Kg followed by 0.2-0.7 µg/Kg/hour according to each patient

which in addition to the orally prescribed drugs; on admission to the ICU, the Pheo-patient has serum-Mg level measurement \& a bolus of 40 mg/kg MgSo₄ is given I.V. \& may be repeated until the therapeutic level of MgSo₄ 2-4 mmol/Liter is reached (7\&10). Dexmedetomidine sedation is started the evening prior to surgery by loading dose of 1µg/Kg followed by 0.2-0.7 µg/Kg/hour according to each patient

1) Traditional group in which the patients̕ hemodynamic adjustment will be conducted using orally or IV α₁ \& β-adrenergic blockers \[Prazocin (minipress): 0.5-20 mg/day, Propranolol (Inderal) :10-360 mg/day, Bisoprolol (Concor): 2.5-20 mg/day, Atenolol (Tenormin): 25-100 mg/day \&/or Labetalol (Trandate)200-600 mg/day, ACI \& ACRB e.g. Tritace 2.5-10 mg/day \& Atacand 4-16 mg/day\]

Ehab H Shaker, MD

Pheochromocytoma (pheo) is a catecholamine secreting tumor arising from chromaffin cells of the adrenal medulla in 90% of cases \& in 10% is extra-adrenal arising from the sympathetic chain. It is malignant in 10% of cases, bilateral in 10% of patients \& 10% of all pheo are inherited (Familial Pheo) as autosomal dominant either alone or as a part of multiple endocrine neoplasia (MEN) syndrome.In this prospective work, the investigators will try to compare the peri-operative hemodynamic course of Dexmedetomidine \& magnesium sulphate (MgSo₄) infused patients with the traditional anesthetic technique (α₁ \& β-adrenergic blockers plus vasodilators) during open surgical resection of Pheo. The investigators are aiming to check the safety \& efficacy of the recommended technique on the peri-operative hemodynamic stability \& controlling the hypertensive crisis during tumor manipulation.

Pheochromocytoma (pheo) is a catecholamine secreting tumor arising from chromaffin cells of the adrenal medulla in 90% of cases \& in 10% is extra-adrenal arising from the sympathetic chain. It is malignant in 10% of cases, bilateral in 10% of patients \& 10% of all pheo are inherited (Familial Pheo) as autosomal dominant either alone or as a part of multiple endocrine neoplasia (MEN) syndrome.The anesthetic management of Pheo during surgical resection is usually challenging \& faces many cardiovascular risks as tachycardia, arrhythmias, severe hypertension \& may be pulmonary edema \& profound hypotension after surgical devascularization of the tumor. These dangerous events are sequelae of catecholamine excess and often are refractory to management . The proper anesthetic control is based on the use of α₁ \& β-adrenergic blockers (phenoxy-benzamine, phentolamine, propranolol, labetalol) and vasodilators such as glycerine trinitrate (GTN) \& sodium nitroprusside (SNP) .The rational of using magnesium sulphate MgSo₄ infusion to control catecholamine levels \& catecholamine-related crisis has been established in several clinical emergencies such as severe tetanus \& preoperative management of pre-eclampsia \& eclampsia . MgSo₄ beneficial cardiovascular effects may be attributed to its ability to reduce catecholamine release from the adrenal medulla \& to reduce α-adrenergic receptors sensitivity to catecholamines . MgSo₄ is also a direct vasodilator \& a potent anti-arrhythmic drug particularly with high circulatory catecholamine level . The safety of MgSo₄ in the routine clinical range of 2-4 mmol/Liter is well settled in many clinical works.

There is strong evidence that the sympathetic nervous system is intact in Pheo patients \& neurons-released noradrenaline plays a fundamental role in blood pressure BP regulation. Dexmedetomidine is a short acting \& highly selective central α₂-agonist that inhibits neuronal firing \& thereby induces analgesia, anxiolysis, bradycardia \& hypotension. It has been tried to attenuate the sympathetic pressor effect of tracheal intubation, cardiac surgeries \& emergence from anesthesia .The unique adventitious anesthetic pharmacology induces preoperative sedation, intra-operative hemodynamic stability beside reducing the anesthetic requirements and adding to post-operative analgesia . Its peri-operative use has been suggested in both pediatric \& adult patients of Pheo.

In this prospective work,the investigators tried to compare the peri-operative hemodynamic course of Dexmedetomidine \& MgSo₄ infused patients with the traditional anesthetic technique (α₁ \& β-adrenergic blockers plus vasodilators) during open surgical resection of Pheo. The investigators are aiming to check the safety \& efficacy of this recommended technique on the peri-operative hemodynamic stability \& controlling the hypertensive crisis during tumor manipulation.

the Effect of Dexmedetomidine and Magnesium Sulfate in Open Resection of Pheochromocytoma

The Perioperative Use of Dexmedetomidine and Magnesium Sulfate Compared With Traditional Anesthetic Technique for Open Resection of Pheochromocytoma.

National Cancer Institute, Egypt

lecturer of anesthesia ,critical care and pain medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erector Spinae Plane Block Versus Paravertebral Block	NCT03471442	Breast Cancer Pain, Postopera... Anesthesia, Loc...	Paravertebral b... Erector spinae ... General anesthe... Opioids Anesthetics, Lo...	18 Years -	University of Alberta
Erector Spinae Plane Block Versus Paravertebral Block	NCT03471442	Breast Cancer Pain, Postopera... Anesthesia, Loc...	Paravertebral b... Erector spinae ... General anesthe... Opioids Anesthetics, Lo...	18 Years -	University of Alberta
the Effect of Dexmedetomidine and Magnesium Sulfate in Open Resection of Pheochromocytoma	NCT04320589	Pheochromocytom...	Dexmedetomidine General anesthe...	12 Years - 69 Years	National Cancer Institute, Egypt
the Effect of Dexmedetomidine and Magnesium Sulfate in Open Resection of Pheochromocytoma	NCT04320589	Pheochromocytom...	Dexmedetomidine General anesthe...	12 Years - 69 Years	National Cancer Institute, Egypt

Spots Global Cancer Trial Database for general anesthetic