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Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670759
Recruitment Status : Terminated (A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.)
First Posted : February 2, 2016
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
Intensity of postoperative pain [ Time Frame: 24 hours following surgery ]
Will be assessed using a Verbal Numeric Pain Scale (VPNS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • Opioid intake [ Time Frame: From surgery until 72 hours following surgery ]
  • Side-effects attributable to analgesia [ Time Frame: From surgery until 72 hours following surgery ]
    The presence of nausea and vomiting will be recorded
  • Patient's satisfaction with pain relief [ Time Frame: Daily from surgery until 72 hours following surgery ]
    Will be assessed using a scale from 1 to 4: 1 being completely dissatisfied and 4 being completely satisfied
  • Length of stay in the recovery room [ Time Frame: At discharge from recovery room, approximately 1 hour after end of surgery ]
  • Length of stay in the intermediate intensive care unit [ Time Frame: From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day. ]
  • Length of stay in the hospital [ Time Frame: From surgery until discharge from the hospital, approximately 2 days ]
  • Lung function [ Time Frame: Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days ]
    Will be measured using a peak flow meter
  • Pulmonary complications [ Time Frame: From surgery until 72 hours following surgery ]
    Occurence of atelectasis or pneumonia will be noted
  • Time to reach discharge criteria [ Time Frame: From the day after surgery until discharge from the hospital, approximately 2 days ]
    Will be assessed using the Post Anesthesia Discharge Score (PADS)
  • Intensity of postoperative pain [ Time Frame: 48 hours following surgery ]
    Will be assessed using a Verbal Numeric Pain Scale (VPNS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
  • Intensity of postoperative pain [ Time Frame: 72 hours following surgery ]
    Will be assessed using a Verbal Numeric Pain Scale (VPNS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
Official Title  ICMJE Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
Brief Summary

This study is designed to assess:

  • The impact of continuous thoracic paravertebral nerve blockade compared to intercostal nerve blockade on the intensity of postoperative pain following VATS in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
  • The impact of continuous thoracic paravertebral analgesia on length of stay, opioid intake, respiratory function, incidence of side-effects and postoperative complications.

The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade will provide superior postoperative analgesia following VATS when compared to intercostal nerve blockade in patients having a PCA device as their primary analgesic modality. Superior quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake and related side-effects and shorten the hospital stay.

Detailed Description

Appropriate postoperative analgesia is crucial in fast-track surgery, which is a multimodal therapeutic strategy that aims toward enhanced postoperative recovery and shortened hospital stay. Although VATS is considered a minimally invasive procedure, patients have reported moderate to severe pain of variable duration following surgery. The ideal postoperative analgesia regimen for VATS has not been elucidated. Systemic opioids given through patient-controlled devices (PCA) are routinely used after these procedures but their analgesic effect can be limited and undesirable side-effects may occur. Intercostal nerve blockade is also widely used to alleviate pain following VATS and can be used as an adjunct to systemic opioids. Paravertebral nerve blockade is an interesting alternative for analgesia following VATS. The duration of pain relief associated with paravertebral nerve blockade may vary from 4 to 48 hours. However, the duration of the analgesic effect can be prolonged using a continuous infusion of local anesthetics.

This study will compare the efficacy of continuous ambulatory paravertebral analgesia to intercostal analgesia. All patients will have a PCA device as their primary analgesic modality.

Methods:

Seventy patients will be randomized to receive either continuous paravertebral analgesia or intercostal analgesia. Anesthetic technique and monitoring will be standardized.

On arrival in the recovery room, each patient will have a PCA device installed. PCA doses will be standardized. All patients will also receive acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDS) as co-analgesia. PCA will be removed 24 hours after surgery and oral opioids will then be administered as needed.

From their arrival in the recovery room, patients in the paravertebral analgesia group will be administered a bupivacaine 0.0625% infusion through a conventional infusion pump at a rate of 10 mL/h. Before discharge from the hospital on the day following surgery or at the latest on the morning of the second day, the bupivacaine infusion will be transferred to a portable elastomeric pump. The infusion will continue for the next 30 hours at a rate of 10 mL/h.

During the first 72 hours following surgery, the following information will be recorded: intensity of pain, opioid intake, side-effects attributable to analgesia and patient's level of satisfaction towards pain management. The occurence of pulmonary complications will be noted. Lung function will be measured using a peak flow meter. Length of stay in the recovery room, in the intermediate intensive care unit and in the hospital will be recorded. Time to reach post-anesthesia discharge criteria will be recorded.

Patients will be contacted by telephone 2 times a day if hospital discharge occurs before 72 hours after surgery to assess their level of pain and analgesic intake, the presence of side-effects or complications and their satisfaction level towards pain management.

This trial will also include a sub-study to be performed on ten human cadavers. The goal of the sub-study will be to assess the impact of the orientation of the bevel of the paravertebral block needle on the ease of insertion and positioning of the paravertebral catheter using ultrasound imaging.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Continuous infusion of bupivacaine
    The infusion of local anesthetics will be initiated using a conventional infusion pump and will be transferred on a portable elastomeric pump before discharge from the hospital if the patient is discharged the day after surgery or at the latest on the second morning following surgery. The infusion will continue on the portable pump for 30 hours.
  • Drug: Single dose of bupivacaine
    A single dose of bupivacaine will be administered at the end of surgery before skin closure.
Study Arms  ICMJE
  • Experimental: Paravertebral analgesia
    A paravertebral nerve block will be performed under ultrasound guidance by the anaesthesiologist prior to the induction of general anesthesia. A catheter will be inserted and a continuous infusion of bupivacaine will be administered.
    Intervention: Drug: Continuous infusion of bupivacaine
  • Active Comparator: Intercostal analgesia
    An intercostal nerve block using a single dose of bupivacaine will be performed by the surgeon at the end of surgery before skin closure.
    Intervention: Drug: Single dose of bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2018)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
70
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for an elective or emergency VATS surgery (lobectomy or bilobectomy)
  • Patients eligible for fast-track surgery
  • American Society of Anesthesiologists (ASA) physical status from 1 to 3

Exclusion Criteria:

  • Contraindication to paravertebral nerve blockade
  • Severe hepatic insufficiency
  • Renal insufficiency
  • Known allergy to local anesthetics, morphine or hydromorphone
  • Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs (NSAID)
  • Inability to understand a verbal numeric pain scale despite previous instruction
  • Inability to understand the instructions and precautions related to the use of a portable infusion pump or absence of a resource person or natural caregiver at home
  • Preexisting pain at the site where the surgical incision will be made
  • Current use of opioids, anticonvulsants or tricyclic antidepressants
  • Recent history of drug or opioid abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670759
Other Study ID Numbers  ICMJE 15.291
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sebastien Garneau, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP