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Preventing Chronic Post Surgical Pain After Limb Surgery (PCPSPAULS)

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brachial plexus block
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring pain, surgical, brachial plexus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Trauma patient undergoing orthopedic surgery for upper extremity or shoulder
  2. Age >18 and < 75 years
  3. Both males and females
  4. Understand English (reading, writing and speaking)
  5. Patient gives a written consent for being involved in this study

Exclusion Criteria:

  1. Patient with any sort of chronic pain including fibromyalgia
  2. Patient using opioids for >90 days
  3. Patient who had an associated injury related to the trauma apart from that limb
  4. Patient who need more than one surgery to fix the problem
  5. Patient diagnosed with major depression
  6. Failed or partially effective block
  7. Bilateral surgical intervention

Sites / Locations

  • St. Joseph's Hospital
  • LHSC, SJHC, Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study (first group)

Controlled (second group)

Arm Description

The first group will include those who receive a single shot brachial plexus block with or without general anesthesia.

The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon.

Outcomes

Primary Outcome Measures

Chronic Post Surgical Pain

Secondary Outcome Measures

Full Information

First Posted
August 11, 2015
Last Updated
September 23, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02630498
Brief Title
Preventing Chronic Post Surgical Pain After Limb Surgery
Acronym
PCPSPAULS
Official Title
The Role of Single Shot Brachial Plexus Block in Preventing Chronic Post Surgical Pain After Upper Limb Trauma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
It was not practical to continue recruiting due to lack of human resources
Study Start Date
August 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first group will include those who receive a single shot brachial plexus (interscalene, supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon
Detailed Description
This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first group will include those who receive a single shot brachial plexus (interscalene, supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon. Patients will not be randomized for this study because regional anesthesia is proven to reduce acute postoperative pain and reduce the need for opioids. However, investigators will involve all patients who meet the inclusion criteria and give consent to participate in this study within the period of study between September 1st 2015 and February 28th 2017 (18 months). The block is usually performed with ultrasound guidance by the block Room team at both sites (consultant, fellow and resident). Block success will be checked and documented. Ropivacaine is the standard local anesthetic used in the block room at LHSC (University Hospital) and SJHC. However, the type of local anesthetics and the total volume are difficult to be standardized for all patients in this study, so it will be neglected during analysis. The block room at SJHC and LHSC perform around 100 blocks per month. Thirty percent of these blocks are for upper limb procedures. The same number of patients undergoes these procedures with no blocks at both SJHC and LHSC. Investigators expect to involve around 100 patients in each arm during the study period. All patients will be followed up for 6 months through filling a questionnaire and Brief Pain Inventory (BPI), which assess pain score and pain interference scale. The follow up will be through mail and /or phone call. Sample Size There is no previous study data provided the prevalence of CPSP in similar surgical procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
pain, surgical, brachial plexus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
study (first group)
Arm Type
Experimental
Arm Description
The first group will include those who receive a single shot brachial plexus block with or without general anesthesia.
Arm Title
Controlled (second group)
Arm Type
No Intervention
Arm Description
The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon.
Intervention Type
Procedure
Intervention Name(s)
Brachial plexus block
Intervention Description
Patients receiving brachial plexus block for hand/arm surgery
Primary Outcome Measure Information:
Title
Chronic Post Surgical Pain
Time Frame
Upto six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma patient undergoing orthopedic surgery for upper extremity or shoulder Age >18 and < 75 years Both males and females Understand English (reading, writing and speaking) Patient gives a written consent for being involved in this study Exclusion Criteria: Patient with any sort of chronic pain including fibromyalgia Patient using opioids for >90 days Patient who had an associated injury related to the trauma apart from that limb Patient who need more than one surgery to fix the problem Patient diagnosed with major depression Failed or partially effective block Bilateral surgical intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Dhir, FRCPC
Organizational Affiliation
LHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
LHSC, SJHC, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preventing Chronic Post Surgical Pain After Limb Surgery

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