Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery

Effect of Infraclavicular Nerve Block Versus General Anaesthesia for Acute Postoperative Pain After Distal Radial Fracture Surgery

This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: General anaesthesia; Procedure: Infraclavicular nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: General Anaesthesia; Patients would receive routine general anaesthesia for their distal radial fracture surgery	Procedure: General anaesthesia; Usual practice for upper limb surgeries.
Experimental: Regional Anaesthesia; Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery	Procedure: Infraclavicular nerve block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute postoperative pain score	pain score would be recorded on postoperative day 1 using numeral rating scale	At postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain score	chronic pain score would be recorded on postoperative 3rd month using numeral rating scale	At postoperative 3rd month
Analgesic drug consumption	Total analgesic drug consumption would be recorded on discharge day base on drug record from patient record	On discharge day

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Nerve block; Infraclavicular; Acute pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Acute Pain; Radius Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: UW16-005

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No