Clinical trial NCT03048214: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: Nerve block; Infraclavicular; Acute pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acute postoperative pain score
timeFrame: At postoperative day 1
Secondary outcomes:
measure: Chronic pain score
timeFrame: At postoperative 3rd month
measure: Analgesic drug consumption
timeFrame: On discharge day
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Stanley SC Wong, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.