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Local Anesthetic

Active Comparator: Transversus abdominis plane (TAP) block performed in operating room for Local Anesthesia

N/A

Recruiting

Led By Justin Hruska, MD

Research Sponsored by Justin Hruska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Consent received to receive a TAP block

Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours following tap block]

Awards & highlights

Study Summary

This trial aims to test a new method of administering a pain-relieving technique called Transversus Abdominus Plane (TAP) blocks during minimally invasive gynecologic surgeries. The traditional method

Who is the study for?

This trial is for patients undergoing minimally invasive gynecologic surgeries. Participants should be those who require post-operative pain management and are suitable candidates for receiving a Transversus Abdominis Plane (TAP) block, which is an anesthesia technique.Check my eligibility

What is being tested?

The study tests if performing TAP blocks while the abdomen is inflated with air during surgery leads to better pain control after surgery compared to the traditional method of doing it after deflation.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, bleeding, infection risk, or inadequate pain relief. Since it's local anesthesia, systemic side effects are less common than with general anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have agreed to receive a TAP block.

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I am a woman aged 18-85, scheduled for a gynecological laparoscopic procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours following tap block]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours following tap block]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours following tap block] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ease of performing TAP Block-anatomical plane visualization

Ease of performing TAP Block-performance efficacy

Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery

+8 more

Trial Design

2Treatment groups

Active Control

Group I: Active Comparator: Transversus abdominis plane (TAP) block performed in operating roomActive Control1 Intervention

The treatment group will have a transversus abdominis plane (TAP) block performed prior to closing surgical port sites post-operatively in an insufflated abdomen in the operating room (OR). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses.

Group II: Transversus abdominis plane (TAP) block performed in PACUActive Control1 Intervention

The treatment group will have a transversus abdominis plane (TAP) block performed post-operatively after the patient has been transferred from the Operating Room to the Post Anesthesia Care Unit (PACU). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Justin HruskaLead Sponsor

Justin Hruska, MDPrincipal InvestigatorWayne State University/Detroit Medical Center

Frequently Asked Questions

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

Who is eligible to participate in this medical research study?

"To be eligible for this research study, individuals must present with the requirement of local anesthesia and fall within the age bracket of 18 to 85 years. The trial aims to enroll approximately 120 participants."

Answered by AI

Is this clinical trial open to individuals aged 75 and older?

"To participate in this research, individuals aged between 18 and 85 are sought for recruitment. Notably, there are separate clinical trials available: 7 designated for participants under 18 years old, and 28 geared towards those above the age of 65."

Answered by AI

Are participants currently being actively recruited for this research study?

"As per clinicaltrials.gov, this current trial is actively seeking participants. The trial was initially uploaded on June 22nd, 2023 and last revised on February 20th, 2024."

Answered by AI

What is the total number of subjects being examined in this particular research investigation?

"Affirmative. The information available on clinicaltrials.gov confirms the active recruitment status of this clinical trial. Initially posted on June 22nd, 2023, and most recently updated on February 20th, 2024, the study aims to enroll a total of 120 participants from two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Transversus Abdominis Plane Block

Justin Hruska 2023. "Efficacy of Transversus Abdominis Plane Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06274307.

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