Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections

December 5, 2016 updated by: Stamford Hospital

Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study

The control of postoperative pain has become a major issue in surgery awareness and it is considered an important measurement of patient satisfaction. Improvements in pain relief, including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to the surgical patient. When pain is aggressively addressed, patients respond by recovering faster.

The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting local anesthetic wound infiltration has been widely recognized as a useful adjunct to multimodal postoperative pain management. On that basis, a system that delivers a continuous local anesthetic to the surgical wound was developed, and better pain control has been achieved after several surgical procedures.

In patients undergoing abdominal procedures, such as colon resection, adequate pain control remains an issue. It is known that innervation to the antero-lateral abdomen is provided by sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been described and has shown to be effective for immediate postoperative pain control.

Recently, the use of the On-Q pain relief system with catheters placed within the TAP has been evaluated. Published results have shown significant improvement of pain control (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of prospective trials investigating the effectiveness of a continuous wound infusion with local anesthetics after general surgery procedures the investigators sought to determine the efficacy of this technique after laparoscopic colon resection procedures.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
      • Stamford, Connecticut, United States, 06902
        • Colon and Rectal Surgery

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

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
  • Patients must be able to read and write English.

Exclusion Criteria:

  • Patients undergoing open procedures.
  • Lap converted to open procedures.
  • Patients with known liver dysfunction, or the following laboratory assays: ALT/AST/alk. Phos/total bilirubin of 2x ULN
  • Cirrhosis Child's class A-C, INR >1.5. There is no specific isolated value of protein or albumin which would disqualify the subject.
  • All emergent/urgent cases taken to the OR for colon resections.
  • All patients with previous drug abuse/narcotic abuse history.
  • Patients without the mental capacity to consent for the procedure/study.
  • Subjects requiring a translator in order to sign the informed consent.
  • Subjects with a history of an allergic reaction to local anesthetics or acetaminophen.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine
Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
Drug: 0.2% ropivacaine
On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
Other Names:
  • Experimental drug
Placebo Comparator: Saline
Subjects with TAP catheters attached to the On-Q pump with saline
Drug: Saline
On-Q pumps containing saline to be attached to TAP catheters
Other Names:
  • Control/Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to flatus
Time Frame: 1 week
Post-operative time measurement for the patient to pass flatus
1 week
Hospital Length of Stay
Time Frame: 1 week
Post-operative time measurement until patient discharge
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passage of Stool
Time Frame: 1 week
Post-operative time measurement for the patient to pass stool
1 week
Narcotic use
Time Frame: 1 week
Post-operative measurement of patient narcotic requirements
1 week

Collaborators and Investigators

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

Sponsor

Stamford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 3, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-1017.01

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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