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

May 1, 2012
May 3, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01592630 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Colorectal Disorders
  • Observation of Neuromuscular Block
  • Drug: 0.2% ropivacaine
    On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
    Other Name: Experimental drug
  • Drug: Saline
    On-Q pumps containing saline to be attached to TAP catheters
    Other Name: Control/Placebo
  • Experimental: Ropivacaine
    Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
    Intervention: Drug: 0.2% ropivacaine
  • Placebo Comparator: Saline
    Subjects with TAP catheters attached to the On-Q pump with saline
    Intervention: Drug: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Charles Littlejohn, MD 203-323-8989 cd000684@mindspring.com
Contact: Preetha Umamaheswaran, MD 203-276-7152 pumamaheswaran@stamhealth.org
United States
 
NCT01592630
11-1017.01
Yes
Preetha Umamaheswaran, Stamford Hospital
Stamford Hospital
Not Provided
Not Provided
Stamford Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP