Preventing Chronic Post Surgical Pain After Limb Surgery

Not Applicable

Terminated

• Conditions: Chronic Pain
• Interventions: Procedure: Brachial plexus block

• Registration Number: NCT02630498
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study (first group)	Brachial plexus block	The first group will include those who receive a single shot brachial plexus block with or without general anesthesia.

Primary Outcome Measures

Name	Time	Method
Chronic Post Surgical Pain	Upto six months

Trial Locations

Locations (2)

St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada

LHSC, SJHC, Western University; 🇨🇦 London, Ontario, Canada