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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Anesthesia
• Interventions: Drug: TAP Block

• Registration Number: NCT01479270
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-24
• Study Completion: 2012-01
• Results First Submitted: 2018-05-10
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-05
• Last Update Submitted: 2018-10-05
• Results First Posted: 2018-10-11
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2	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

Name	Time	Method
Intraoperative Time	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.
Narcotic Use	Postop Day #0 and Day #1	narcotic use in mg of Morphine will be recorded
Visual Analog Scale (VAS) for Pain	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.)