TAP Block for Postoperative Pain Control

October 30, 2018 updated by: Joshua Herskovic

Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control

This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to give written informed consent
  • Scheduled for open abdominal surgery
  • American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

  • Inability to understand the study or provide written informed consent
  • Inability to follow protocol instructions
  • Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
  • Allergy to local anesthetic agents
  • Contraindication to regional nerve block such as:
  • Bleeding disorder
  • Sepsis
  • Infection at site of block
  • Body Mass Index (BMI) >40
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Single Injection of Bupivacaine
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Drug: Bupivacaine
60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
Other Names:
  • Marcaine
  • Sensorcaine
Active Comparator: Single Injection of Exparel®
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Drug: Exparel®
20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
Other Names:
  • bupivacaine liposome injectable suspension
Active Comparator: Continuous infusion of Ropivacaine
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Drug: Ropivacaine
40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Dosage of Narcotic
Time Frame: 3 postoperative days
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
3 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Vomiting (Events)
Time Frame: 3 postoperative days
Total number of vomiting episodes over the three postoperative days.
3 postoperative days
Patient Reported Pain by VAS Scale
Time Frame: Postoperative Day 1
Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Postoperative Day 1
Patient Reported Pain by VAS Scale
Time Frame: Postoperative Day 2
Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Postoperative Day 2
Patient Reported Pain by VAS Scale
Time Frame: Postoperative Day 3
Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Postoperative Day 3
Number of Days Required for a Patient to Get Out of Bed
Time Frame: Assessed daily for up to 3 days post-surgery
Patients will be assessed each day following the day of surgery for the ability to get out of bed.
Assessed daily for up to 3 days post-surgery
Number of Days Required for a Patient to Walk Unassisted
Time Frame: Assessed daily for up to 3 days post-surgery
Patients will be assessed each day following the day of surgery for the ability to walk unassisted
Assessed daily for up to 3 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joshua Herskovic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua Herskovic, MD, Midwestern Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZ2014035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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