CLINICAL TRIAL

Bupivicaine HCl for Pain, Postoperative

Recruiting · 18+ · Female · New Hyde Park, NY

This study is evaluating whether a specific type of nerve block may help reduce pain after surgery.

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About the trial for Pain, Postoperative

Eligible Conditions
Pain, Postoperative · Revisions · Augmentation · Mastopexy · Outpatient Breast Surgery

Treatment Groups

This trial involves 2 different treatments. Bupivicaine HCl is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Bupivicaine HCl
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Normal Saline
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivicaine HCl
2017
Completed Phase 2
~570

Side Effect Profile for Cohort 2, Group 2: HTX-011 + Ropivacaine

Cohort 2, Group 2: HTX-011 + Ropivacaine
Show all side effects
Nausea
54%
Constipation
38%
Vomiting
25%
Tachycardia
16%
Dizziness
14%
Hypertension
14%
Pyrexia
14%
Leukocytosis
11%
Hypokalaemia
11%
Insomnia
11%
Anxiety
7%
Pruritus
7%
Urinary retention
7%
Muscle spasms
5%
Hyperthermia
5%
Gamma-glutamyltransferase increased
4%
Headache
4%
Anaemia postoperative
4%
Hyperglycaemia
4%
Hypotension
4%
Dyspepsia
4%
Pruritus generalised
4%
Medical device site reaction
4%
Incision site erythema
2%
Arthralgia
2%
Postoperative fever
2%
Chills
2%
Dyspnoea
2%
Post procedural cellulitis
2%
Pulmonary embolism
2%
Respiratory failure
2%
Urinary tract infection
2%
Anaemia
2%
Lethargy
2%
Erythema
2%
Feeling cold
2%
Thrombocytosis
2%
Respiratory depression
2%
Contusion
2%
Pain in extremity
0%
Peripheral swelling
0%
Oedema peripheral
0%
Dysphonia
0%
Gastrooesophageal reflux disease
0%
Pain
0%
Retching
0%
Dysphagia
0%
Inflammation
0%
Sciatica
0%
Hypoxia
0%
Syncope
0%
Atrial fibrillation
0%
Post procedural haematoma
0%
Cholecystitis acute
0%
Haematoma
0%
Hyperkalaemia
0%
Hyponatraemia
0%
Confusional state
0%
Paraesthesia
0%
Supraventricular tachycardia
0%
Asthenia
0%
Dry mouth
0%
Hyperhidrosis
0%
Post procedural complication
0%
Oral herpes
0%
Wound drainage
0%
Sinus tachycardia
0%
Joint swelling
0%
Incision site oedema
0%
Fatigue
0%
Wound dehiscence
0%
Laryngospasm
0%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03015532) in the Cohort 2, Group 2: HTX-011 + Ropivacaine ARM group. Side effects include: Nausea with 54%, Constipation with 38%, Vomiting with 25%, Tachycardia with 16%, Dizziness with 14%.

Eligibility

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.
ASA I-III.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 to 10 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 to 10 hours.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bupivicaine HCl will improve 1 primary outcome and 5 secondary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of 1 week.

Patient satisfaction with Likert scale
1 WEEK
Patient satisfaction with pain management
Incidence of postoperative nausea and vomiting
4 TO 10 HOURS
Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded
Postoperative pain with Numeric Rating Scale
4 TO 10 HOURS
Pain assessed at timed intervals at rest and movement during postoperative period.
Postoperative opioid requirements
4 TO 10 HOURS
Incidence of antiemetic use
4 TO 10 HOURS
The proportion of patients who required antiemetics during the postoperative period.
PACU length of stay
4 TO 10 HOURS
Time to PACU discharge

Who is running the study

Principal Investigator
J. A.
Judith Aronsohn, MD
Northwell Health

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pain, postoperative?

The authors provide common pain treatment and postoperative treatment protocols, along with a rating guideline to assist in patient-centered pain management and communication. In the article, all patient-centered pain management and communication should be evaluated, with special attention to postoperative pain control. If there is no one standardized postoperative analgesic regimen, then the authors recommend individualized postoperative analgesia based on patient-specific risk factors.

Anonymous Patient Answer

What causes pain, postoperative?

It is important for surgeons to realize that some patients will be much more sensitive to general anesthesia than others. Some patients need less anesthesia, and some less. This variability in sensitivity can be caused by differences in the shape, size, and innervation of the blood vessels in the skin, termed anatomic vasculature. Patients without angiographically demonstrable arteries, or with one that is less than normal by ultrasound, are unlikely to experience pain after surgery. Patients with a "normal" vasculature, defined as having arteries that are larger than normal by ultrasound but smaller by manual examination, will be much more sensitive. The type of anesthesia used does not appear to affect these correlations.

Anonymous Patient Answer

What are the signs of pain, postoperative?

The most common signs of postoperative pain that are apparent within the first 24 hours after surgery are decreased range of motion, increased pain during activities, and increased cough frequency. Patients receiving epidural analgesia are less likely to complain of increased pain during ambulation than those receiving systemic opioids.

Anonymous Patient Answer

Can pain, postoperative be cured?

It is difficult to identify a certain period after surgery when the postoperative pain would be fully gone or has been fully fixed; although some allevication is achieved, it can not be regarded as complete.

Anonymous Patient Answer

How many people get pain, postoperative a year in the United States?

Every year, a total of 9.3 million postoperative surgical cases are performed in the United States; thus, postoperative pain is a major problem. Anesthesiologists perform over 800,000 surgeries a year, and they are particularly at risk for the development of postoperative pain.

Anonymous Patient Answer

What is pain, postoperative?

In this paper pain, postoperative pain, is discussed separately from cancer pain during the course of the disease, in palliative care and after the treatment endpoints. The paper addresses this topic through the eyes of a palliative care physician whose patients are in the postoperative period, and how to deal with the pain experience of the disease. To deal with this experience it is necessary to have a palliative care physician in a comprehensive multidisciplinary team.

Anonymous Patient Answer

What is the latest research for pain, postoperative?

Postoperative pain is a significant issue for all patients undergoing surgery, including those with cancer; therefore, the development of specific pain relief and monitoring strategies are of interest. This review focuses on the most recent research.

Anonymous Patient Answer

What are the latest developments in bupivicaine hcl for therapeutic use?

Bupivicaine, as a local anesthetic for dental work, is highly effective in alleviating pain when used during surgical techniques (incisions, drainage tubes, etc..) without any systemic side effects. In addition, it is an effective spinal anesthetic in short and long-term use and has a shorter duration (45-60 min) as compared to other spinal medications; this reduces hospital stay and patient discomfort and reduces the need of post-operative analgesics. Bupivicaine has good blood serum levels; therefore, it should not not be administered to patients with renal failure.

Anonymous Patient Answer

Has bupivicaine hcl proven to be more effective than a placebo?

At the end of the study the bupivicaine group showed significant improvement of pain in both the immediate post-operative period (on the first three post-operative days) and after 6 weeks of follow up. The study showed no difference for the patient's comfort with either of the 2 groups of morphine.

Anonymous Patient Answer

What is the primary cause of pain, postoperative?

There was some evidence to suggest [mature teratoma is one of the causes of painful tumor enlargement at the time of initial surgery in patients with nonfunctioning pituitary adenoma. Also, there were some cases in which patients had postoperative residual pain, but this pain did not correlate with the postoperative tumor size or complications during or after surgery] that mature teratoma is one of the cause of postoperative pain after surgical intervention in patients with a nonfunctioning pituitary adenoma. Further studies on this topic will provide more information.

Anonymous Patient Answer

Who should consider clinical trials for pain, postoperative?

We found that half of all patients with surgical pain and that a third of all patients with postoperative or postoperative pain will qualify for enrollment in clinical trials. Patients must be informed about and have the information they need to make a valid informed decision about the clinical trial. Pain management specialists and surgeons should consider referral to clinical trials for postoperative pain management.

Anonymous Patient Answer

How serious can pain, postoperative be?

Recent findings suggest that moderate postoperative pain may still not be as serious as previously thought and is not a legitimate justification for the withholding of effective pain relieving treatment in elderly women.

Anonymous Patient Answer
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