(TAP) Block vs. Systemic Lidocaine: Effects on Recovery (TAP)

Tranversus Abdominis Plane (TAP) Block vs. Systemic Lidocaine to Improve Quality of Recovery After Outpatient Laparoscopic Surgery: A Non-inferiority, Randomized, Double Blinded, Placebo Controlled Trial

It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients. Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors. Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is particularly desirable since those patients do not have access to potent intravenous medications and nursing support after hospital discharge.

Our group has previously demonstrated that both TAP block and systemic lidocaine improve quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block, however, requires expertise, equipment (ultrasound), and additional time to perform as compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine infusion provides non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

The main objective of the current investigation is to examine the effect of TAP block on quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

Significance: This is the first study to compare systemic lidocaine to TAP block with regard to quality of recovery.

The research question; does systemic lidocaine provide similar quality of recovery as TAP block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior quality of recovery as TAP block for outpatient laparoscopy.

Research significance: It has been shown that females have poor surgical recovery compared to males; this project intends to demonstrate that systemic lidocaine provides similar recovery as TAP blocks but it does not require the expertise, equipment, and time needed to perform TAP blocks.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Surgery
• Intervention / Treatment: Drug: Systemic lidocaine; Drug: TAP BLOCK with ropivacaine

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: 18-65 years of age
• Surgery type: Outpatient Gynecological Laparoscopy
• ASA status: I and II
• Fluent in English

Exclusion Criteria:

• History of allergy to local anesthetics
• History of chronic opioid use
• Pregnant patients
• Drop Out: Conversion to open surgery, patient or surgeon request.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Systemic lidocaine; Systemic lidocaine group will receive a lidocaine 1.5 mg/kg bolus after induction of anesthesia followed by a 2mg/kg/hr infusion and sham bilateral TAP blocks with normal saline 15mL on each side.	Drug: Systemic lidocaine; Systemic lidocaine group will receive a lidocaine 1.5 mg/kg bolus after induction of anesthesia followed by a 2mg/kg/hr infusion and sham bilateral TAP blocks with normal saline 15mL on each side.; Other Names: lidocaine 1 %
Active Comparator: TAP BLOCK with ropivacaine; TAP block will receive bilateral TAP blocks using ultrasound guidance with 0.5% ropivacaine 15mL on each side and a bolus and infusion of normal saline after induction of anesthesia.	Drug: TAP BLOCK with ropivacaine; TAP block group will receive bilateral TAP blocks using ultrasound guidance with 0.5% ropivacaine 15mL on each side and a bolus and infusion of normal saline after induction of anesthesia.; Other Names: Ropivacaine .5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoR-40 global score at 24 hours	QoR-40 global score at 24 hours	24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption at 24 hours post operative	Total amount of morphine used in the 24 hour period post operative.	24 hours post operative

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Meghan Rodes, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Gynecology; Postoperative; TAP block; Anesthesiology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: STU00086849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO