Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Infraclavicular nerve block
General anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Nerve block; Infraclavicular; Acute pain
Eligibility Criteria
Inclusion Criteria:
- ASA I-III
- Age 18-80 years old
- Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)
Exclusion Criteria:
- Surgery involving more than distal radial fracture of the affected arm
- Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
- History of chronic pain
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
- Patients with liver dysfunction (Plasma bilirubin over 34 mol/L, INR >/=1.7, ALT and AST over 100U/L)
- Pre-existing neurological or muscular disorders
- Psychiatric illness
- Impaired or retarded mental state
- Not self-ambulatory before operation
- Pregnancy
- Local infection
- Patient refusal
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
General Anaesthesia
Regional Anaesthesia
Arm Description
Patients would receive routine general anaesthesia for their distal radial fracture surgery
Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery
Outcomes
Primary Outcome Measures
Acute postoperative pain score
pain score would be recorded on postoperative day 1 using numeral rating scale
Secondary Outcome Measures
Chronic pain score
chronic pain score would be recorded on postoperative 3rd month using numeral rating scale
Analgesic drug consumption
Total analgesic drug consumption would be recorded on discharge day base on drug record from patient record
Full Information
NCT ID
NCT03048214
First Posted
January 23, 2017
Last Updated
March 14, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03048214
Brief Title
Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery
Official Title
Effect of Infraclavicular Nerve Block Versus General Anaesthesia for Acute Postoperative Pain After Distal Radial Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
July 13, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.
Detailed Description
A single blinded randomized control trial will be performed to compare regional anaesthesia with single shot infraclavicular nerve block versus general anaesthesia.
The primary outcome was postoperative NRS pain score (0-10) with movement at 24 hours after surgery. No suitable references for postoperative NRS pain scores at 24 hours that could be used for sample size calculation was found. Based on a previous study on RA versus GA for hand surgery, the standard deviation estimate of the treatments for sample size calculation was 2.86. To detect a difference in NRS pain score of 2.4/10 at a significance level of 0.05 and a power of 0.80, the minimum number of patients required per group was 23. A difference of 2.4 in NRS pain score was chosen because this has been shown to correspond to 'much improvement' in pain relief, which is clinically significant. To take into account for possible dropouts, 26 patients were recruited into each group.
Patients will be approached in the general ward before operation. The aims of the study and need for follow up assessment would be explained and patient will be recruited only if s/he agrees. After agreeing to join the study, patients will be randomly allocated to one of two groups: 1) General anaesthesia (GA) 2) Regional Anaesthesia with infraclavicular block (RA). Outcomes of patients in receiving general anaesthesia (GA) will be compared with patients receiving infraclavicular nerve block (RA).
Data Analysis Intention-to-treat will be used. Patients will remain in their initial designated groups for data analysis even if there is a change in surgical or anaesthetic/analgesic management, as long as they are undergoing distal radial fracture surgery not involving another operative site (eg bone graft). Patients in the RA group who required conversion to general anaesthesia due to inadequate infraclavicular block would remain in the RA group for data analysis.
Statistical methods used:
Incidence of chronic post surgical pain: Chi-Square test
NRS pain scores at 3 and 6 months after surgery: Mann-Whitney test to look at difference in mean pain scores between two groups
duration of anaesthetic, analgesic and surgical procedures, time to extubation, cumulative opioid consumption, dose and frequency of rescue analgesic used, time to food intake and ambulation, time to discharge, patient satisfaction: Kruskal-Wallis test
Acute NRS pain scores over 48 hours: Postoperative NRS pain scores were expressed in median (interquartile range) and analyzed using Mann-Whitney U test with post-hoc multiple comparisons using Bonferroni procedure
Patient demographic data: One way ANOVA and chi-square test.
Intraoperative vital signs, HRQOL, HADS, DASH-HKPWH: Repeated measures ANOVA (with Bonferroni correction when appropriate)
Side effects and postoperative complications: Chi Square test
When a significant result is obtained, t-test or Mann-Whitney test for numerical values and Chi-square test for categorical data will be applied for post hoc pairwise comparisons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Nerve block; Infraclavicular; Acute pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Anaesthesia
Arm Type
Sham Comparator
Arm Description
Patients would receive routine general anaesthesia for their distal radial fracture surgery
Arm Title
Regional Anaesthesia
Arm Type
Experimental
Arm Description
Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery
Intervention Type
Procedure
Intervention Name(s)
Infraclavicular nerve block
Intervention Description
Infraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers.
Intervention Type
Procedure
Intervention Name(s)
General anaesthesia
Intervention Description
Usual practice for upper limb surgeries.
Primary Outcome Measure Information:
Title
Acute postoperative pain score
Description
pain score would be recorded on postoperative day 1 using numeral rating scale
Time Frame
At postoperative day 1
Secondary Outcome Measure Information:
Title
Chronic pain score
Description
chronic pain score would be recorded on postoperative 3rd month using numeral rating scale
Time Frame
At postoperative 3rd month
Title
Analgesic drug consumption
Description
Total analgesic drug consumption would be recorded on discharge day base on drug record from patient record
Time Frame
On discharge day
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:
ASA I-III
Age 18-80 years old
Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)
Exclusion Criteria:
Surgery involving more than distal radial fracture of the affected arm
Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
History of chronic pain
Alcohol or drug abuse
Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
Patients with liver dysfunction (Plasma bilirubin over 34 mol/L, INR >/=1.7, ALT and AST over 100U/L)
Pre-existing neurological or muscular disorders
Psychiatric illness
Impaired or retarded mental state
Not self-ambulatory before operation
Pregnancy
Local infection
Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley SC Wong, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15277930
Citation
McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028. Erratum In: Anesthesiology. 2004 Oct;101(4):1057.
Results Reference
background
PubMed Identifier
14499431
Citation
Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.
Results Reference
background
PubMed Identifier
32466746
Citation
Wong SS, Chan WS, Fang C, Chan CW, Lau TW, Leung F, Cheung CW. Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. BMC Anesthesiol. 2020 May 28;20(1):130. doi: 10.1186/s12871-020-01044-4.
Results Reference
derived
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Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery
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