Preventing Chronic Post Surgical Pain After Limb Surgery

Chronic Pain Clinical Trial

— PCPSPAULS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02630498
• Other study ID #: HSREB 105321
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Procedure:
• Brachial plexus block
Patients receiving brachial plexus block for hand/arm surgery

Locations

Country	Name	City	State
Canada	LHSC, SJHC, Western University	London	Ontario
Canada	St. Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Post Surgical Pain		Upto six months