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

This study is currently recruiting participants.
Verified May 2012 by Stamford Hospital
Sponsor:
Information provided by (Responsible Party):
Preetha Umamaheswaran, Stamford Hospital
ClinicalTrials.gov Identifier:
NCT01592630
First received: May 1, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Colorectal Disorders
Observation of Neuromuscular Block
Drug: 0.2% ropivacaine
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stamford Hospital:

Primary Outcome Measures:
  • Time to flatus [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Post-operative time measurement for the patient to pass flatus

  • Hospital Length of Stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Post-operative time measurement until patient discharge


Secondary Outcome Measures:
  • Passage of Stool [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Post-operative time measurement for the patient to pass stool

  • Narcotic use [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Post-operative measurement of patient narcotic requirements


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Control/Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592630

Contacts
Contact: Charles Littlejohn, MD 203-323-8989 cd000684@mindspring.com
Contact: Preetha Umamaheswaran, MD 203-276-7152 pumamaheswaran@stamhealth.org

Locations
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
Contact: Preetha Umamaheswaran, MD    203-276-7152    pumamaheswaran@stamhealth.org   
Contact: Ryan Bendl, DO    203-276-7152    rbendl@stamhealth.org   
Principal Investigator: Preetha Umamaheswaran, MD         
Sub-Investigator: Ryan F Bendl, DO         
Sub-Investigator: Vlad Frenk, MD         
Sub-Investigator: Theresa Bowling, MD         
Colon and Rectal Surgery Recruiting
Stamford, Connecticut, United States, 06902
Contact: Charles Littlejohn, MD    203-323-8989    cd000684@mindspring.com   
Contact: Steven J McClane, MD    203-323-8989    sjmcclane@aol.com   
Principal Investigator: Charles Littlejohn, MD         
Sub-Investigator: Steven J McClane, MD         
Sponsors and Collaborators
Stamford Hospital
  More Information

Publications:

Responsible Party: Preetha Umamaheswaran, Resident Physician, Department of Surgery, Stamford Hospital
ClinicalTrials.gov Identifier: NCT01592630     History of Changes
Other Study ID Numbers: 11-1017.01
Study First Received: May 1, 2012
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014