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

Sponsor
Stamford Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01592630
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
12
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to flatus [1 week]

      Post-operative time measurement for the patient to pass flatus

    2. Hospital Length of Stay [1 week]

      Post-operative time measurement until patient discharge

    Secondary Outcome Measures

    1. Passage of Stool [1 week]

      Post-operative time measurement for the patient to pass stool

    2. Narcotic use [1 week]

      Post-operative measurement of patient narcotic requirements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colon and Rectal Surgery Stamford Connecticut United States 06902
    2 Stamford Hospital Stamford Connecticut United States 06904

    Sponsors and Collaborators

    • Stamford Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Stamford Hospital
    ClinicalTrials.gov Identifier:
    NCT01592630
    Other Study ID Numbers:
    • 11-1017.01
    First Posted:
    May 7, 2012
    Last Update Posted:
    Dec 6, 2016
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Ropivacaine

    Study Results

    No Results Posted as of Dec 6, 2016