search
Back to results

Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous infusion of bupivacaine
Single dose of bupivacaine
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paravertebral analgesia

Intercostal analgesia

Arm Description

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.

An intercostal nerve block using a single dose of bupivacaine will be performed by the surgeon at the end of surgery before skin closure.

Outcomes

Primary Outcome Measures

Intensity of postoperative pain
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

Secondary Outcome Measures

Opioid intake
Side-effects attributable to analgesia
The presence of nausea and vomiting will be recorded
Patient's satisfaction with pain relief
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
Length of stay in the intermediate intensive care unit
Length of stay in the hospital
Lung function
Will be measured using a peak flow meter
Pulmonary complications
Occurence of atelectasis or pneumonia will be noted
Time to reach discharge criteria
Will be assessed using the Post Anesthesia Discharge Score (PADS)
Intensity of postoperative pain
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
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

Full Information

First Posted
January 18, 2016
Last Updated
June 16, 2019
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT02670759
Brief Title
Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
Official Title
Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Intercostal analgesia
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Continuous infusion of bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Single dose of bupivacaine
Intervention Description
A single dose of bupivacaine will be administered at the end of surgery before skin closure.
Primary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
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
Time Frame
24 hours following surgery
Secondary Outcome Measure Information:
Title
Opioid intake
Time Frame
From surgery until 72 hours following surgery
Title
Side-effects attributable to analgesia
Description
The presence of nausea and vomiting will be recorded
Time Frame
From surgery until 72 hours following surgery
Title
Patient's satisfaction with pain relief
Description
Will be assessed using a scale from 1 to 4: 1 being completely dissatisfied and 4 being completely satisfied
Time Frame
Daily from surgery until 72 hours following surgery
Title
Length of stay in the recovery room
Time Frame
At discharge from recovery room, approximately 1 hour after end of surgery
Title
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.
Title
Length of stay in the hospital
Time Frame
From surgery until discharge from the hospital, approximately 2 days
Title
Lung function
Description
Will be measured using a peak flow meter
Time Frame
Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days
Title
Pulmonary complications
Description
Occurence of atelectasis or pneumonia will be noted
Time Frame
From surgery until 72 hours following surgery
Title
Time to reach discharge criteria
Description
Will be assessed using the Post Anesthesia Discharge Score (PADS)
Time Frame
From the day after surgery until discharge from the hospital, approximately 2 days
Title
Intensity of postoperative pain
Description
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
Time Frame
48 hours following surgery
Title
Intensity of postoperative pain
Description
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
Time Frame
72 hours following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Garneau, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

We'll reach out to this number within 24 hrs