Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery, specifically laparoscopic gynecological surgery.

Study Overview

• Status: Withdrawn
• Conditions: Laparoscopy; Gynecologic Surgery; Quality of Recovery
• Intervention / Treatment: Drug: placebo; Drug: duloxetine

Detailed Description

It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients.1 Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors.2, 3 Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy.4 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.

In addition, pain after ambulatory surgery remains an unsolved problem in The United States and Europe.5,6 It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including NSAIDs, acetaminophen, membrane stabilizers, ketamine, and local and regional anesthetic techniques.7,8 Both serotonin and norepinephrine have involvement in modulation of pain mechanisms in the central nervous system. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor that has been used for mitigation of pain in such conditions as chronic musculoskeletal pain, diabetic peripheral neuropathic pain, post-herpetic neuralgia, and fibromyalgia.9,10 Duloxetine was also found to reduce postoperative morphine requirements in patients undergoing knee replacement surgery.11 The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery.12 This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of duloxetine.

A suicidal behavior questionnaire (SBQ-R) will be used to screen for suicidal risk among potential subjects. If any subject exhibits suicidal ideation as a result of scoring high on the questionnaire, there surgeon and/or primary care provider will be notified by the principal investigator.

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery.

Significance: Use of preoperative duloxetine may improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Prentice Womens Hospital

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:

• outpatient gynecological laparoscopy
• ASA PS 1 and 2
• fluent in English

Exclusion Criteria:

• history of allergy to duloxetine, history of chronic opioid use, pregnant patients, preoperative SSRI or SNRI use, prolonged QT interval on ECG

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; placebo	Drug: placebo; placebo
EXPERIMENTAL: Duloxetine; duloxetine 60mg PO	Drug: duloxetine; patients will be randomized to receive either duloxetine or placebo; Other Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QOR-40 global score	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	measure intraoperative opioid consumption in morphine IV equivalents in mg	1 hour

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (ESTIMATE): January 30, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: duloxetine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: STU00096889