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

Colorectal Disorders research study

What is the primary objective of this 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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Colorectal Disorders

Observation of Neuromuscular Block

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:0.2% ropivacaineOn-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters

Drug:SalineOn-Q pumps containing saline to be attached to TAP catheters

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

RopivacaineSubjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine

SalineSubjects with TAP catheters attached to the On-Q pump with saline

Study Status

Withdrawn

Start Date: May 2012

Completed Date: May 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Time to flatus

Secondary Outcome: Passage of Stool

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Stamford Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01592630

Gupta A, Fant F, Axelsson K, Sandblom D, Rykowski J, Johansson JE, Andersson SO. Postoperative analgesia after radical retropubic prostatectomy: a double-blind comparison between low thoracic epidural and patient-controlled intravenous analgesia. Anesthesiology. 2006 Oct;105(4):784-93.

Discuss Flatulence