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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
Results First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Pollard, MetroHealth Medical Center

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 Phase
Pain, Postoperative Anesthesia Drug: TAP Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
Drug Information available for: Epinephrine

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
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other Name: Ropivacaine with Epinephrine

No Intervention: No Block
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.



Primary Outcome Measures :
  1. Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 [ Time Frame: Postop Day #1 or Day #2 ]
    40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).


Secondary Outcome Measures :
  1. Narcotic Use [ Time Frame: Postop Day #0 and Day #1 ]
    narcotic use in mg of Morphine will be recorded

  2. Visual Analog Scale (VAS) for Pain [ Time Frame: 2 and 24 hours post operative ]
    visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)

  3. Intraoperative Time [ Time Frame: the total intraoperative time in minutes ]
    The total time in the operating room will be recorded to see if there is a difference between groups.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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
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Principal Investigator: Sarah M Kane, MD MetroHealth Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Pollard, Clinical Fellow, Principal Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01479270    
Other Study ID Numbers: IRB10-01517
First Posted: November 24, 2011    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by Robert Pollard, MetroHealth Medical Center:
recovery
postoperative
pain
laparoscopy
hysterectomy
ropivacaine
TAP block
local anesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Epinephrine
Ropivacaine
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