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This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anaesthesia | Sham Comparator | Patients would receive routine general anaesthesia for their distal radial fracture surgery |
|
| Regional Anaesthesia | Experimental | Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infraclavicular nerve block | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley SC Wong, MBBS | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15277930 | Background | 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. | |
| 14499431 | Background |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General anaesthesia | Procedure | Usual practice for upper limb surgeries. |
|
| On discharge day |
| 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. |
| 32466746 | Derived | 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. |