Transversus Abdominis Plane (TAP) Block for Cesarean Section

NCT01015807 | Completed Results DMC

• 1 other identifier: 36707
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.

Conditions

Hyperalgesia, Secondary

Keywords

postoperative; hyperalgesia; pain; transversus abdominis plane block; TAP block; cesarean section

Outcome Measures

Primary Outcomes (1)

• Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups

  Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.

  48hrs after CS

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo

Drug: Bupivacaine Placebo; Drug: Clonidine Placebo

TAP (Bupi)

ACTIVE COMPARATOR

2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo

Drug: Clonidine Placebo; Drug: Bupivacaine

Clo-TAP (Bupi + Clon)

ACTIVE COMPARATOR

2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

Drug: Bupivacaine; Drug: Clonidine

Interventions

Bupivacaine Placebo DRUG

2 x 20mL 0.9% NaCl

Also known as: Bupi Placebo, Sodium Chloride

Placebo

Clonidine Placebo DRUG

2 x 1mL 0.9% NaCl

Also known as: Sodium Chloride

Placebo; TAP (Bupi)

Bupivacaine DRUG

2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine

Also known as: Bupivacaine Hydrochloride

Clo-TAP (Bupi + Clon); TAP (Bupi)

Clonidine DRUG

2 x 1ml Clonidine = 150 µg Clonidine

Also known as: Clonidine Hydrochloride

Clo-TAP (Bupi + Clon)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia
• English speaking (UW Site) or Portuguese speaking (Brazil site)
• aged between 18 and 45 years
• BMI \< 40
• ASA physical status class I or II

You may not qualify if:

• laboring women undergoing a non-scheduled cesarean delivery
• non-English speaking (UW Site) or non-Portuguese speaking (Brazil site)
• previous spinal surgery
• contraindications for neuraxial anesthesia
• allergy to local anesthetic, ultrasound conduction gel, or Clonidine
• history of chronic pain
• inability to receive intraoperative Toradol

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

University of Washington

Seattle, Washington, 98195, United States

Location

Hospital e Maternidade Santa Joana

São Paulo, 04103-080, Brazil

Location

Related Publications (24)

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• Gabriel JS, Gordin V. Alpha 2 agonists in regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2001 Dec;14(6):751-3. doi: 10.1097/00001503-200112000-00024.

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• Landau R, Schiffer E, Morales M, Savoldelli G, Kern C. The dose-sparing effect of clonidine added to ropivacaine for labor epidural analgesia. Anesth Analg. 2002 Sep;95(3):728-34, table of contents. doi: 10.1097/00000539-200209000-00036.

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• Lavand'homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol. 2006 Jun;19(3):244-8. doi: 10.1097/01.aco.0000192815.22989.61.

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  PMID: 16960491 BACKGROUND

• Lavand'homme P, De Kock M, Waterloos H. Intraoperative epidural analgesia combined with ketamine provides effective preventive analgesia in patients undergoing major digestive surgery. Anesthesiology. 2005 Oct;103(4):813-20. doi: 10.1097/00000542-200510000-00020.

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• Lavand'homme PM, Roelants F, Waterloos H, Collet V, De Kock MF. An evaluation of the postoperative antihyperalgesic and analgesic effects of intrathecal clonidine administered during elective cesarean delivery. Anesth Analg. 2008 Sep;107(3):948-55. doi: 10.1213/ane.0b013e31817f1595.

  PMID: 18713912 BACKGROUND

• Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. doi: 10.1097/01.anes.0000267606.17387.1d.

  PMID: 17525598 BACKGROUND

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• McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

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MeSH Terms

Conditions

Hyperalgesia; Pain

Interventions

Sodium Chloride; Bupivacaine; Clonidine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Laurent Bollag
• Organization: Univerisity of Washington

bollag@uw.edu

+12063277328

Study Officials

• Ruth Landau, MD

  University of Washington

  STUDY CHAIR

• Laurent Bollag, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2012
• Last Updated: October 23, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (1)