Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 56
- Primary Endpoint
- Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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 (Drug)
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)
Investigators
Robert Pollard
Clinical Fellow, Principal Investigator
MetroHealth Medical Center