Preventing Chronic Post Surgical Pain After Limb Surgery (PCPSPAULS)

The Role of Single Shot Brachial Plexus Block in Preventing Chronic Post Surgical Pain After Upper Limb Trauma Surgery

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

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: Brachial plexus block

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital
    • London, Ontario, Canada, N6A 5A5
      • LHSC, SJHC, Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study (first group); The first group will include those who receive a single shot brachial plexus block with or without general anesthesia.	Procedure: Brachial plexus block; Patients receiving brachial plexus block for hand/arm surgery
NO_INTERVENTION: Controlled (second group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Chronic Post Surgical Pain	Upto six months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shalini Dhir, FRCPC, LHSC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (ESTIMATE): December 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pain; surgical; brachial plexus
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: HSREB 105321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO