Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Syndrome

Recurrence

Breast Neoplasms

Pain, Postoperative

Nausea

Vomiting

Postoperative Nausea and Vomiting

Pain

Hyperalgesia

Postoperative Complications

Neurologic Manifestations

Signs and Symptoms, Digestive

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Anti-Arrhythmia Agents

Antihypertensive Agents

Anesthetics

Fentanyl

Analgesics, Opioid

Esmolol

Metoprolol

Adrenergic beta-Antagonists

Narcotics

Adrenergic Agents

Anesthetics, Intravenous

Anesthetics, General

Adrenergic Antagonists

Neurotransmitter Agents

Adrenergic beta-1 Receptor Antagonists

Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control

Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.

fentanyl

esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

beta-blocker (esmolol, metropolol)

Etienne de Medicis, MD MSc

The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.

Postoperative Analgesia Impact of Narcotic Free Anesthesia

The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

Université de Sherbrooke

Doctor

Head and Neck Neoplasms

Antipyretics

Pharmaceutical Solutions

Anticonvulsants

Psychotropic Drugs

Acetaminophen

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.

Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.

Use of Gabapentin peri- and post-operatively.

Use of sugar-free Placebo peri- and post-operatively.

Placebo - Concentrate

Arnaud Bewley, MD

Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.

Patients undergoing head and neck cancer surgery frequently experience significant post surgical pain, which often necessitates the use of narcotic pain medication. However, opioids can have multiple side effects that can complicate the head and neck cancer surgery patients postoperative care including nausea, vomiting, dizziness, sedation, pruritis, urinary retention, delirium, constipation, and time to ambulation. This, in turn, may affect patient length and cost of hospital stay. Consequently, a multimodal approach to analgesia is often employed with a focus on use of scheduled acetaminophen +/- NSAIDs supplemented with narcotics.

The use of gabapentin in the head and neck surgery literature has largely been limited to outpatient surgeries, including tonsillectomy in children and adults, functional endoscopic sinus surgery, and thyroidectomy. Indeed, a recent systematic review examined RCT comparing multimodal analgesia with gabapentin to analgesia without gabapentin in the otolaryngology literature. The majority of these studies employed preoperative dosing only, with only 1 study providing a single postoperative dose as well. The control group pain regimen among these studies did vary and included a combination of acetaminophen, NSAIDs, dexmedetomidine, or clonidine supplemented with opioids. The studies focused on the impact of gabapentin on acute postoperative pain determined by subjective measurement of reduction in visual analog pain scale. Of note, these patients were not hospitalized for longer than 24 hours. The thyroid and sinus studies consistently demonstrated improved pain control with use of gabapentin compared to control. The data was slightly more variable across the tonsillectomy studies. Moreover, 7 studies also measured the need for breakthrough pain medication and supplemental analgesia; each of these studies demonstrated significantly less supplemental analgesia consumption in the gabapentin group.

The only study examining the utility of gabapentin in pain management in head and neck cancer patients (glossectomy with anterolateral thigh free flap) examined the utility of a single preoperative dose. The authors concluded that this led to a significant reduction in subjective postoperative pain scores, morphine requirement, and nausea and vomiting compared to controls. This study did not employ postoperative gabapentin.

Furthermore, a recent meta analysis (133 RCT) examining literature across multiple surgical specialties pertaining to the efficacy of perioperative gabapentin supplementation vs placebo. The meta analysis indicated both the efficacy of gabapentin supplementation in decreasing opioid requirement (measured via morphine equivalent units) in the experimental group during the first 24 hours (P\<0.001), as well as a good safety profile across a wide range of loading and maintenance doses (200 to 1200 mg) of gabapentin. The significant reduction in opioid requirement was independent of surgery type. Moreover, the gabapentin group demonstrated a significant decrease in VAS postoperative pain scores, nausea, vomiting and itching; however, sedation scores were increased. Only 8 of these 133 RCT examined the effect of gabapentin outside the immediate 24 hour period, and all 8 trials demonstrated improvement in chronic pain scores at 3 months post-operatively. Finally, patient satisfaction scores and preoperative anxiety were also significantly improved with the use of gabapentin compared to controls.

Here, the investigators propose, for the first time, a superiority double blind randomized controlled placebo trial examining the effect of perioperative supplementation with gabapentin in head and neck cancer patients undergoing surgery. The primary purpose of this study is to determine the difference in morphine equivalent units between the experimental (i.e. perioperative gabapentin) and control group (i.e. no perioperative gabapentin). The secondary purpose of this study is to determine differences across the two groups in relation to the following: visual analog pain scores, cost and length of stay, medication side effects, and incidence of postoperative complications. Of note, in order to maximize reliability of the visual analog scale (VAS), prior studies have employed the Jadad scoring system, which the investigators will also implement in the study.

All staff involved including nursing, surgeons, pain management, participants and PI will be blinded. Unmasked personnel only include research pharmacy staff.

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery: A Randomized Controlled Trial

Determine the difference in average morphine equivalent units between experimental and control group.

Determine average change of inpatient Pain Score Visual Analog Scale (VAS) on a standardized 1 (no pain) to 10 (highest level of pain) scale between experimental and control groups.

Incidence of postoperative complications between experimental and control group.

Incidence of narcotics-related complications between experimental and control group.

Determine the difference of average inpatient length of stay between experimental and control group.

Determine the difference of average inpatient cost between experimental and control group.

University of California, Davis

Any known untoward event of any severity that occurs subsequent to the AE reporting period that the Investigator assesses as at least possibly related to the study therapy (i.e., the relationship cannot be ruled out) should also be reported as an AE.

Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.

Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively.

Control

Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.

Gabapentin: Use of Gabapentin peri- and post-operatively.

Intervention

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Early study termination was decided after several technical issues regarding study logistics and patient non-compliance lead to unreliable and uninterpretable data.

Arnaud Bewley

Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Analgesia Impact of Narcotic Free Anesthesia	NCT01544959	Pain, Postopera... Breast Cancer Postoperative N...	fentanyl beta-blocker (e...	18 Years - 65 Years	Université de Sherbrooke
Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery	NCT03682367	Cancer of Head ... Narcotic Use	Gabapentin Placebo - Conce...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for narcotic

Every month we try and update this database with for narcotic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for narcotic

Every month we try and update this database with for narcotic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for narcotic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.