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

NCT02053558 | Withdrawn

• 1 other identifier: STU00086849
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain; Surgery

Keywords

Anesthesiology; Pain; TAP block; Gynecology; Postoperative; Analgesia

Outcome Measures

Primary Outcomes (1)

• QoR-40 global score at 24 hours

  QoR-40 global score at 24 hours

  24 hours post operative

Secondary Outcomes (1)

• Morphine consumption at 24 hours post operative

  24 hours post operative

Study Arms (2)

Systemic lidocaine

PLACEBO COMPARATOR

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

TAP BLOCK with ropivacaine

ACTIVE COMPARATOR

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

Interventions

Systemic lidocaine DRUG

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.

Also known as: lidocaine 1 %

Systemic lidocaine

TAP BLOCK with ropivacaine DRUG

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.

Also known as: Ropivacaine .5%

TAP BLOCK with ropivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Meghan Rodes, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: November 3, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share