INL-001 (bupivacaine hydrochloride) implant for Hernia, Ventral

Phase-Based Estimates
2
Effectiveness
3
Safety
Memorial Hermann, Houston, TX
Hernia, Ventral+6 More
INL-001 (bupivacaine hydrochloride) implant - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Hernia, Ventral

Study Summary

This study is evaluating whether a new type of painkiller may be effective for treating pain following surgery.

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Eligible Conditions

  • Hernia, Ventral
  • Pain, Postoperative
  • Hernia
  • Reduction Mammoplasty
  • Abdominoplasty
  • Colectomy
  • Hysterectomy

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether INL-001 (bupivacaine hydrochloride) implant will improve 1 primary outcome, 7 secondary outcomes, and 8 other outcomes in patients with Hernia, Ventral. Measurement will happen over the course of 0 to 24 hours.

0 to 24 hours
SPI24
0 to 48 hours
SPI48
Hour 48
Total use of opioid rescue analgesia
0 to 72 Hours
SPI72
Hour 96
AUC
AUC0-∞
Cmax
Tlag
Tmax
t½ Terminal Half life
λz
Hour 96
Opioid-related Symptom Distress Scale (OR-SDS)
Day 7
15-item Quality of Recovery (QoR-15) Questionnaire
Patient Global Assessment (PGA) as Related to Postoperative Pain
Day 30
Evaluate the safety and tolerability
Immediately after the intervention/procedure/surgery
Time to discharge from the postanesthesia care unit (PACU)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
INL-001 (bupivacaine hydrochloride) implant

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. INL-001 (bupivacaine Hydrochloride) Implant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

INL-001 (bupivacaine hydrochloride) implant
CombinationProduct
INL-001 (bupivacaine hydrochloride) implant
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours for reporting.

Closest Location

Memorial Hermann - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has a body mass index of 18-35 kg/m2.
Has a planned (nonemergency) open ventral hernia repair, abdominoplasty (with rectus sheath plication, in the opinion of the surgeon), open abdominal hysterectomy, laparoscopic-assisted colectomy, or reduction mammoplasty to be conducted using standard surgical technique under general anesthesia.
Has the ability and willingness to comply with all study procedures including being domiciled for at least 96 hours after surgery.
Is willing to use opioid analgesia, if needed.

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 the signs of hernia, ventral?

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The first diagnostic clue in diagnosing hernia, ventral is a sudden pain in the abdominal region, more specifically beneath the pubic bone and between the pubic bone and the medial part of the rectum. This pain is accompanied with itching, but can be diagnosed without any medical imaging (i.e., ultrasound). After that, surgical intervention is required, since hernia is a serious but treatable disease.

Unverified Answer

What are common treatments for hernia, ventral?

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Hernias are one of the most common medical conditions reported for female patients. In this prospective study, we found there was no clear consensus of the most appropriate surgery and most commonly recommended technique: transabdominal, transperitoneal and laparoscopic approaches. Further, in our sample, the majority of patients also had a history of pelvic surgery, and a substantial number had a history of pelvic infection.

Unverified Answer

What causes hernia, ventral?

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Hernia, ventral is a common reason for many visits to the GP, although it is a rare, benign reason for the patient to see their GP. Most hernias were caused in the mid-sixties and late seventies.

Unverified Answer

Can hernia, ventral be cured?

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In the last 20 years, new and advanced surgical techniques have led to a good outcome for many ventral hernia patients. All patients must take their operation as a stressful experience and must have a realistic expectation for their outcome. The aim of the treatment should be to achieve a very good quality of life for the patients.

Unverified Answer

How many people get hernia, ventral a year in the United States?

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Around 15.6 million US adults are currently diagnosed with hernia. This makes up 5.6% of American adults. For the first time, this study attempts to investigate the trend in hernia, ventral (Abdominal wall) incidence in different parts of the United States.

Unverified Answer

What is hernia, ventral?

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Viscera are covered by the parietal peritoneum which is made of two layers, a middle one and an inner one. During fetal development, both layers become apposed as one. This process allows the formation of a sac known as a hernia. At birth, the most common hernias are inguinal, which include the hernia sac of the spermatic cord and the umbilicus. The most common site of a ventral hernia is the lower third of the vagina. There are no gender or developmental differences in the herniation rate for ventral hernias of the scrotum. Although most hernias are small, they usually require surgery.

Unverified Answer

What does inl-001 (bupivacaine hydrochloride) implant usually treat?

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Inl-001(bupivacaine hydrochloride) implant has no clinical benefit on the outcomes compared to a placebo for the treatment of inguinal and femoral hernia. The implant is safe and feasible for postoperative pain following inguinal and femoral hernia repair.

Unverified Answer

Have there been other clinical trials involving inl-001 (bupivacaine hydrochloride) implant?

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The clinical usefulness of inl-001 (bupivacaine hydrochloride gel insert) for sciatica remains unknown. Bursal block may be an effective method for symptomatic relief of sciatica. We concluded that inl-001 implant is a new and effective method for sciatica.

Unverified Answer

What are the common side effects of inl-001 (bupivacaine hydrochloride) implant?

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The most frequent adverse side effects in the inl-001 group were transient adverse reactions such as pain, edema, and hematoma. A statistically significant difference was noted in the number and severity of adverse events between inl-001 and placebo in both genders.

Unverified Answer

What is the latest research for hernia, ventral?

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Ventral hernia is an uncommon disease. It is the result of weakness in hernioventricular or hernial rings. Current surgical management techniques are safe and effective. Other advances include mesh placement, bioresorbable implants, and aortic repair techniques. In addition there is growing evidence that using a mesh, instead of a suture, when the mesh can be made to be permanently implanted into hernioventricular rings is better for the repairs, especially in older, obese, and female patients. If your surgeon is not using this approach then ask for a biopsy for analysis of the implants. Further research would be helpful.

Unverified Answer

What is the primary cause of hernia, ventral?

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Hernias are thought to be caused by inguinal hernias occurring as a result of the weakness of the fascia of the abdominal wall or of the defect due to birth trauma after presenting with abdominal pain. For children who have a VOM, an opening in the fascia allows stool to escape from the abdominal cavity. These children can also have a ventral hernia. Hernias most commonly presenting with pain in the VOM region are more likely to have a hernia at the site of a birth defect. In patients with a VOM without birth trauma, there is a risk that a VOM is a congenital condition. Thus neonates with VOM need to be followed for anomalies.

Unverified Answer

Who should consider clinical trials for hernia, ventral?

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Most of the patients who met one of the three following criteria were at risk to participate in a clinical trial as well as to show no response to the treatment: age greater than 60 years old, overweight/obese, and prior abdominal surgery. Data from a recent study showed that the first three criteria were the most effective at identifying patients to participate in clinical trials, and patients older than 60 who received the suture or mesh procedure showed no response to the treatment. There were also many patients who had an unsuccessful suture procedure but were asymptomatic that also benefited from treatments. The last criteria did not make any difference in clinical outcomes, but patients who were symptomatic, older than 55, or obese did show no response to treatment.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Hernia, Ventral by sharing your contact details with the study coordinator.