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

NCT01592630 | Withdrawn Phase 3 DMC

• 1 other identifier: 11-1017.01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Disorders; Observation of Neuromuscular Block

Outcome Measures

Primary Outcomes (2)

• Time to flatus

  Post-operative time measurement for the patient to pass flatus

  1 week

• Hospital Length of Stay

  Post-operative time measurement until patient discharge

  1 week

Secondary Outcomes (2)

• Passage of Stool

  1 week

• Narcotic use

  1 week

Study Arms (2)

Ropivacaine

EXPERIMENTAL

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

Drug: 0.2% ropivacaine

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

0.2% ropivacaine DRUG

On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters

Also known as: Experimental drug

Ropivacaine

Saline DRUG

On-Q pumps containing saline to be attached to TAP catheters

Also known as: Control/Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
• Patients must be able to read and write English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stamford Hospital: lead

Study Sites (2)

Colon and Rectal Surgery

Stamford, Connecticut, 06902, United States

Location

Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

Related Publications (8)

• 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.

  PMID: 17006078 BACKGROUND

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 21457153 BACKGROUND

• 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.

  PMID: 15791370 BACKGROUND

• 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.

  PMID: 2604350 BACKGROUND

• 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.

  PMID: 7963791 BACKGROUND

• 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.

  PMID: 11690726 BACKGROUND

• 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.

  PMID: 21926373 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Drugs, Investigational; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (2)