Transversus Abdominis Plane (TAP) Block for Cesarean Section (CLOTAP)

This study has been terminated.
(Limited number of eligible patients.)
Sponsor:
Information provided by (Responsible Party):
Laurent Bollag, University of Washington
ClinicalTrials.gov Identifier:
NCT01015807
First received: November 16, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hyperalgesia, Secondary
Drug: Bupivacaine Placebo
Drug: Clonidine Placebo
Drug: Bupivacaine
Drug: Clonidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Transversus Abdominis Plane (TAP) Block for Cesarean Section

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To 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. [ Time Frame: 48hrs after CS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine which of three different TAP formulations has the most beneficial effect on the postoperative area of hyperalgesia 24 hrs after the start of the CS [ Time Frame: 24 hrs after CS ] [ Designated as safety issue: No ]
  • To determine which of the three different TAP groups has the most beneficial effect on the postoperative amount of static hyperalgesia 24 and 48hrs after the start of the CS [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate pain scores at rest and during movement at 6, 12, 18, 24, 36 and 48hrs after the surgery [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate the time it takes for a woman to ask for the first analgesic medication after the surgery [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate postoperative morphine consumption (or equivalent of morphine) during the first 48hrs after the surgery [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate the correlation between preoperative mechanical temporal summation (mTS) and amount of hyperalgesia and postoperative pain [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate postoperative side effects such as postoperative nausea and vomiting (PONV), constipation, urinary retention, de-ambulation and motricity [ Time Frame: 48 hrs after CS ] [ Designated as safety issue: No ]
  • To evaluate chronic pain at 3, 6 and 12 months post-surgery by phone with the Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) [ Time Frame: 1 year after CS ] [ Designated as safety issue: No ]
  • To study selected candidate genes related to postoperative pain and analgesics [ Time Frame: 1 year after CS ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Drug: Bupivacaine Placebo
2 x 20mL 0.9% NaCl
Other Names:
  • Bupi Placebo
  • Sodium Chloride
Drug: Clonidine Placebo
2 x 1mL 0.9% NaCl
Other Name: Sodium Chloride
Active Comparator: TAP (Bupi)
2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Drug: Clonidine Placebo
2 x 1mL 0.9% NaCl
Other Name: Sodium Chloride
Drug: Bupivacaine
2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Other Name: Bupivacaine Hydrochloride
Active Comparator: Clo-TAP (Bupi + Clon)
2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Drug: Bupivacaine
2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Other Name: Bupivacaine Hydrochloride
Drug: Clonidine
2 x 1ml Clonidine = 150 µg Clonidine
Other Name: Clonidine Hydrochloride

Detailed Description:

Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain.

The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery.

The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • laboring women undergoing a non-scheduled cesarean delivery
  • non-English speaking
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015807

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Study Chair: Ruth Landau, MD University of Washington
Principal Investigator: Laurent Bollag, MD University of Washington
  More Information

Publications:

Responsible Party: Laurent Bollag, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01015807     History of Changes
Other Study ID Numbers: 36707-K
Study First Received: November 16, 2009
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
postoperative
hyperalgesia
pain
transversus abdominis plane block
TAP block
cesarean section

Additional relevant MeSH terms:
Hyperalgesia
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Bupivacaine
Clonidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Anesthetics
Anesthetics, Local
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014