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Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery (TAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01479270
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

Condition or disease Intervention/treatment
Pain, Postoperative Anesthesia Drug: TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery
Study Start Date : May 2011
Primary Completion Date : September 2011
Study Completion Date : January 2012


Arms and Interventions

Arm Intervention/treatment
Active Comparator: TAP Block
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
Drug: TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other Names:
  • Ropivacaine with Epinephrine
  • TAP Block
No Intervention: No Block
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.


Outcome Measures

Primary Outcome Measures :
  1. QoR-40 survey on postop day #1 [ Time Frame: 48 hours postop ]
    40 question survey completed on paper or by telephone on POD#1 or POD#2


Secondary Outcome Measures :
  1. narcotic use [ Time Frame: 24 hours postop ]
    narcotic use in mg of Morphine will be recorded

  2. VAS for pain [ Time Frame: 24 hours postop ]
    visual analogue scales for pain will be completed on POD#0 and POD#1

  3. Anesthesia time [ Time Frame: intraop ]
    Time of surgery and total time under anesthesia in the OR will be recorded.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient undergoing laparoscopic hysterectomy
  • Age ranges 18-80
  • Reading literacy
  • English speaking
  • Able to give informed consent

Exclusion Criteria:

  • History of relevant drug allergy
  • Chronic opioid users who may have tolerance to pain medications
  • Inability to understand written consent forms or give consent
  • Age less than 18 or over 80
  • Any conversion to open surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479270


Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Sarah M Kane, MD MetroHealth Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Kane, Clinical Fellow, Principal Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01479270     History of Changes
Other Study ID Numbers: IRB10-01517
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

Keywords provided by Sarah Kane, MetroHealth Medical Center:
recovery
postoperative
pain
laparoscopy
hysterectomy
ropivacaine
TAP block
local anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents