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Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Paravertebral nerve blockade
Intercostal nerve blockade
Patient Controlled Analgesia
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 thoracoscopic surgery
  • Physical status 1-4

Exclusion Criteria:

  • Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local infection at the site of injection, spinal deformity)
  • Severe renal or hepatic insufficiency
  • A known allergy to local anesthetics, morphine or hydromorphone
  • The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction
  • Preexisting pain at the site of the surgical incision
  • Current use of opioids, anticonvulsants or tricyclic antidepressants
  • A recent history of drug or opioid abuse
  • Patient refusal

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Paravertebral nerve blockade

Intercostal nerve blockade

Patient Controlled Analgesia (PCA)

Arm Description

A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.

Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room.

Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.

Outcomes

Primary Outcome Measures

Intensity of postoperative pain
Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.

Secondary Outcome Measures

Opioid consumption
Patient's satisfaction with pain relief
Patient's satisfaction with pain relief will be assessed using a scale from 1 to 4 (1=very dissatisfied, 4=very satisfied)
Incidence of chronic pain
Incidence of chronic pain will be assessed using the Brief Pain Inventory questionnaire (BPI)
Length of stay in the recovery room
Length of stay in the intermediate intensive care unit
Length of stay in the hospital

Full Information

First Posted
October 25, 2012
Last Updated
June 5, 2014
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01715701
Brief Title
Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy
Official Title
Efficacy of Multilevel Thoracic Paravertebral Nerve Blockade to Reduce Postoperative Pain Following Video-assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to assess: The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to intercostal nerve blockade performed at the end of surgery on the intensity of postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality. The incidence of chronic pain at 6 months following video-assisted thoracic surgery. The impact of preoperative multilevel paravertebral nerve blockade on patients' quality of life at 6 months following surgery compared to intercostal nerve blockade and to a control group using PCA alone. Hypothesis: The basic hypothesis of this study is that preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will provide superior postoperative analgesia and lower opioid consumption compared to PCA alone during the first 24 hours following surgery. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence of chronic pain at 6 months following surgery. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will shorten the length of stay in the intermediate intensive care unit and shorten the hospital stay. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will reduce postoperative pulmonary complications.
Detailed Description
Video-assisted thoracoscopy is increasing in popularity. Although it is considered a less invasive treatment than thoracotomy, patients have reported moderate to severe pain of variable duration. Benefits of adequate analgesia no longer need to be demonstrated. Optimal analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances patient's satisfaction and quality of life following surgery. Furthermore, adequate postoperative analgesia may reduce the occurrence of chronic pain. The incidence of chronic pain following thoracoscopic procedures ranges from 20-47%. The ideal postoperative analgesia regimen for the pain related to thoracoscopy has not been elucidated. Systemic opioids given through patient-controlled devices (PCA) may be used after thoracoscopic procedures but the analgesic effect can be limited and undesirable side-effects may occur. Thoracic epidural has emerged as the preferred pain control technique following thoracotomy. However, the role of epidural analgesia after thoracoscopy remains debatable. Side-effects may outweigh the benefits of the technique in the context of minimally invasive surgeries. Paravertebral blockade is an alternative to epidural analgesia. The duration of pain relief associated with this technique may vary from 4 to 48 hours. Its effectiveness has been shown to be equal or superior to that of epidural analgesia for post-thoracotomy pain. Its popularity for pain management following thoracotomy has promoted its use after thoracoscopic procedures. Preoperative paravertebral blockade could also result in a reduction of chronic pain following surgery. Intercostal nerve blockade is widely used to alleviate pain following thoracoscopy. This technique is known to provide adequate short-term pain relief. Both paravertebral and intercostal blocks could be interesting adjuncts to patient-controlled devices for pain management following thoracoscopic procedures. This study will compare the efficacy of preoperative paravertebral nerve blockade to intercostal nerve blockade performed before skin closure to PCA alone to reduce the intensity of pain following thoracoscopic procedures. All patients will have a PCA device as their primary analgesic modality.

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral nerve blockade
Arm Type
Experimental
Arm Description
A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.
Arm Title
Intercostal nerve blockade
Arm Type
Active Comparator
Arm Description
Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room.
Arm Title
Patient Controlled Analgesia (PCA)
Arm Type
Active Comparator
Arm Description
Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.
Intervention Type
Procedure
Intervention Name(s)
Paravertebral nerve blockade
Intervention Description
Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
Intervention Type
Procedure
Intervention Name(s)
Intercostal nerve blockade
Intervention Description
Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.
Intervention Type
Procedure
Intervention Name(s)
Patient Controlled Analgesia
Intervention Description
Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
Primary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.
Time Frame
From arrival in the recovery room until 48 hours following surgery
Secondary Outcome Measure Information:
Title
Opioid consumption
Time Frame
From surgery until 48 hours following surgery
Title
Patient's satisfaction with pain relief
Description
Patient's satisfaction with pain relief will be assessed using a scale from 1 to 4 (1=very dissatisfied, 4=very satisfied)
Time Frame
From surgery until 48 hours following surgery
Title
Incidence of chronic pain
Description
Incidence of chronic pain will be assessed using the Brief Pain Inventory questionnaire (BPI)
Time Frame
Six months after surgery
Title
Length of stay in the recovery room
Time Frame
From arrival to discharge from the recovery room (an expected average of one hour)
Title
Length of stay in the intermediate intensive care unit
Time Frame
From arrival to discharge from the intermediate intensive care unit (an expected average of one day)
Title
Length of stay in the hospital
Time Frame
From surgery to discharge from the hospital (an expected average of 2 days)

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 thoracoscopic surgery Physical status 1-4 Exclusion Criteria: Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local infection at the site of injection, spinal deformity) Severe renal or hepatic insufficiency A known allergy to local anesthetics, morphine or hydromorphone The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction Preexisting pain at the site of the surgical incision Current use of opioids, anticonvulsants or tricyclic antidepressants A recent history of drug or opioid abuse Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien 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

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Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy

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