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

Colorectal Disorders Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01592630
• Other study ID #: 11-1017.01
• Status: Withdrawn
• Phase: Phase 3
• First received: May 1, 2012
• Last updated: December 5, 2016
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2016
• Source: Stamford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Disorders
• Observation of Neuromuscular Block

Intervention

Drug:
• 0.2% ropivacaine
On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
• Saline
On-Q pumps containing saline to be attached to TAP catheters

Locations

Country	Name	City	State
United States	Colon and Rectal Surgery	Stamford	Connecticut
United States	Stamford Hospital	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Stamford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Chester JF, Ravindranath K, White BD, Shanahan D, Taylor RS, Lloyd-Williams K. Wound perfusion with bupivacaine: objective evidence for efficacy in postoperative pain relief. Ann R Coll Surg Engl. 1989 Nov;71(6):394-6. — View Citation

De Oliveira GS Jr, Fitzgerald PC, Marcus RJ, Ahmad S, McCarthy RJ. A dose-ranging study of the effect of transversus abdominis block on postoperative quality of recovery and analgesia after outpatient laparoscopy. Anesth Analg. 2011 Nov;113(5):1218-25. doi: 10.1213/ANE.0b013e3182303a1a. — View Citation

Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-7. Review. — View Citation

Faucett J, Gordon N, Levine J. Differences in postoperative pain severity among four ethnic groups. J Pain Symptom Manage. 1994 Aug;9(6):383-9. — View Citation

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. — View Citation

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. — View Citation

Raue W, Haase O, Junghans T, Scharfenberg M, Müller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to flatus	Post-operative time measurement for the patient to pass flatus	1 week	No
Primary	Hospital Length of Stay	Post-operative time measurement until patient discharge	1 week	No
Secondary	Passage of Stool	Post-operative time measurement for the patient to pass stool	1 week	No
Secondary	Narcotic use	Post-operative measurement of patient narcotic requirements	1 week	No