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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Kane, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01479270
First received: November 22, 2011
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Pain, Postoperative
Anesthesia
 Drug: TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • QoR-40 survey on postop day #1 [ Time Frame: 48 hours postop ] [ Designated as safety issue: No ]
    40 question survey completed on paper or by telephone on POD#1 or POD#2


Secondary Outcome Measures:
  • narcotic use [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]
    narcotic use in mg of Morphine will be recorded

  • VAS for pain [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]
    visual analogue scales for pain will be completed on POD#0 and POD#1

  • Anesthesia time [ Time Frame: intraop ] [ Designated as safety issue: No ]
    Time of surgery and total time under anesthesia in the OR will be recorded.


Enrollment: 58
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479270

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

No publications provided by MetroHealth Medical Center

Additional 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
Study First Received: November 22, 2011
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013