Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
NCT ID: NCT01592630
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-05-31
2013-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ropivacaine
Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
0.2% ropivacaine
On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
Saline
Subjects with TAP catheters attached to the On-Q pump with saline
Saline
On-Q pumps containing saline to be attached to TAP catheters
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be able to read and write English.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Stamford Hospital
OTHER
Responsible Party
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Locations
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Colon and Rectal Surgery
Stamford, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
Countries
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References
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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. doi: 10.1097/00000542-200610000-00025.
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. doi: 10.1213/01.ane.0000250223.49963.0f.
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. Epub 2011 Apr 4.
Raue W, Haase O, Junghans T, Scharfenberg M, Muller 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. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26.
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.
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. doi: 10.1016/0885-3924(94)90175-9.
Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
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. Epub 2011 Sep 16.
Other Identifiers
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11-1017.01
Identifier Type: -
Identifier Source: org_study_id