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Clinical Trials/NCT01479270
NCT01479270
Completed
N/A

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

MetroHealth Medical Center0 sites56 target enrollmentMay 2011

Overview

Phase
N/A
Intervention
TAP Block
Conditions
Pain, Postoperative
Sponsor
MetroHealth Medical Center
Enrollment
56
Primary Endpoint
Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
January 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Pollard

Clinical Fellow, Principal Investigator

MetroHealth Medical Center

Eligibility 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

Arms & Interventions

TAP Block

20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.

Intervention: TAP Block

Outcomes

Primary Outcomes

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 Outcomes

  • Intraoperative Time(the total intraoperative time in minutes)
  • Narcotic Use(Postop Day #0 and Day #1)
  • Visual Analog Scale (VAS) for Pain(2 and 24 hours post operative)

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