Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.
Phase: NA
Conditions: Fracture Closed of Lower End of Forearm, Unspecified
Sponsor: Regionshospitalet Viborg, Skive

 
 
02-11-2017 
 
 
 
Ultrasound guided radial and median 
nerve blocks versus haematoma block 
for closed reduction of distal forearm 
fractures; a randomised controlled trial. 
 
Protocol version 1.2, November 2nd, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents 
1. Personnel and inclusion sites…………………………………………………………………………………………………………………….3 
 
1.1 Initiators…………………………………………………………………………………………………………………………..3 
 
1.2 Surgical consultants………………………………………………………………………………………………………….3 
 
1.3 Inclusion sites and local investigators……………………………………………………………………………….4 
 
1.4 Enrolling personnel…………………………………………………………………………………………………………..4 
2. Introduction and background………………………………………………………………………………………………………………….4 
 
2.1 Patient population……………………..…………………………………………………………………………………….4 
 
2.2 Anaesthetic choices for distal forearm fracture reduction…………………………………………………4 
 
2.3 Innervation of the forearm and wrist………………..………………………………………………………………5 
 
2.4 Distal nerve blocks for procedures on the forearm and hand…………….…………………………….5 
 
2.5 Properties of lidocaine……………….…………………………………………………………………………………….5 
3. Hypothesis, aims and outcome………………………….………………………………………………………………………………………5 
 
3.1 Hypothesis……………………………………………………………………………………………………………………….5 
 
3.2 Aim………………………………………………………………..………………………………………………………………..5 
 
3.3 Primary outcome…………………………………………..…………………………………………………………………5 
 
3.4 Secondary outcomes………………………………………………………………………………………………………..5 
4. Study design and conduction…………………………………………………………………………………………………………………..6 
 
4.1 Selection and enrolment of participants……………………………………………………………………………6 
 
 
4.1.1 Recruitment strategy and screening……………………………………..………………..6 
 
 
4.1.2 Inclusion criteria………………………………………………………………….…………………6 
 
 
4.1.3 Exclusion criteria……………………………………………………………..……………………..6 
 
 
4.1.4 Information and consent……………………………………………..…………………………6 
 
 
4.1.5 Participant flow………………………………………………..…………………………………….7 
 
 
4.1.6 Discontinuation and withdrawal…………………………………………………………….7 
 
4.2 Randomisation………………………………………………………………………….……………………………………..7 
 
 
4.2.1 General considerations…………………………………………………………………………..7 
 
 
4.2.2 Intervention group…………………………………………….…………………………………..7 
 
 
4.2.3 Control group…………………………………………………….…………………………………..8 
 
4.3 Blinding……………………………………………………………………………………………………………………………8 
 
4.4 Data collection………………………………………………………………………..……………………………………….8 
 
4.5 Data handling…………………………….…………………………………………………………………………………….9 
 
 
4.5.1 Data management………………………………………………………………………………….9 
 
 
4.5.2 Confidentiality……………………………………………………..…………………………………9 
 
4.6 Data analysis…………………………………………………………………………………………………………………….9 
 
 
4.6.1 Sample size estimation……………………………………….………………………………….9 
 
 
4.6.2 Statistics…………………………………………………………………………………………………9 
5. Ethical concerns…………………………………………………………………………………………………….………………………………….9 
 
5.1 Approvals…………………………………………………………………………………………………………………………9 
 
5.2 Risks and safety considerations……………………………………………………….……………………………….9 
 
5.3 Adverse reactions………………..…………………………………………………………………………………………10 
 
5.4 Gain and benefits……………………………………………………………………………………………………………10 
6. Funding…………………………………………………………………………………………………………………………………………………..10 
7. Publication………………………………………………………………………………………………………………………………………………10 
8. References………………………………………………………………………………………………………………………………………………10 
 
 

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1. Personnel and inclusion sites 
1.1 Initiators 
Anette Bro Christensen, MD (coordinating investigator) 
Department of Anaesthesiology 
Aalborg University Hospital 
Hobrovej 18-22 
9000 Aalborg 
Email: anette.bro.jensen@midt.rm.dk 
Torben Krabbe Laustrup, MD 
Department of Anaesthesia 
Viborg Regional Hospital 
Heibergs Allé 2-4 
8800 Viborg 
Email: torben.krabbe.laustrup@viborg.rm.dk 
Christoffer Grant Sølling, MD, ph.d. (sponsor) 
Department of Anaesthesia 
Viborg Regional Hospital 
Heibergs Allé 2-4 
8800 Viborg 
Email: chrsoell@rm.dk 
1.2 Surgical consultants 
Esben Sejer Pedersen, MD 
Department of Orthopaedic Surgery 
Viborg Regional Hospital 
Heibergs Allé 2-4 
8800 Viborg 
Email: esbepede@rm.dk 
 
 
 
 
 
 
 
 
 
 

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1.3 Inclusion sites and local investigators 
Patients will be included at the Emergency Departments at the following hospitals (more to be added): 
Aalborg University Hospital 
 
Hobrovej 18-22 
 
9000 Aalborg 
 
Local investigator: Jakob Madsen, MD, email: jama@rn.dk 
Viborg Regional Hospital 
 
Heibergs Allé 2-4 
 
8800 Viborg 
 
Local investigator: Torben Laustrup, MD, email: torben.krabbe.laustrup@viborg.rm.dk 
Herning Regional Hospital 
Gl. Landevej 61 
7400 Herning 
Local investigator: Troels Bek Jensen, MD, email: trojense@rm.dk 
Randers Regional Hospital 
Skovlyvej 15 
8930 Randers NØ 
Local investigator: Jacob Keller Andersen, MD, email: Jacob.andersen@rm.dk 
1.4 Enrolling personnel 
At each inclusion site, all anaesthesiologists and anaesthesiologist trainees with sufficient experience to 
perform acute regional anaesthesia will participate in patient screening and inclusion. They will all undergo 
a formal introduction to ensure conformity in injection site and injected volume, prior to their inclusion of 
patients. 
2. Introduction and background 
2.1 Patient population 
Each year, approximately 40.000 patients are diagnosed with a fracture in the distal forearm in Danish 
hospitals(1). While the term Colles’ fracture is widely used to describe all the distal forearm fractures, the 
Danish system for encoding of diagnosis describes a variety of fracture types in the distal forarm including 
three fracture types of the distal radius (code DS525); the Smith fracture (DS525A), the Colles’ fracture 
(DS525B) and the Barton’s fracture (DS525C). Among all dislocated fractures of the distal forearm only the 
true Colles’ fracture can potentially be treated adequately with a closed reduction and a cast, while the other 
fracture types are unstable by definition and require surgical stabilization. Most dislocated forearm fractures, 
however, require a primary reduction and this procedure requires the patient to be relieved of pain and the 
muscle traction on the fracture to be minimal.   
2.2 Anaesthetic choices for distal forearm fracture reduction 
The conventional method of anaesthesia for the reduction of a distal forearm fracture is the haematoma 
block with the local anaesthetic agent being injected directly into the fracture line. This is performed either 
by using a blind technique in which the physician uses the needle to feel his way across the bone surface until 
the fracture line is reached, or by using x-ray to visualize the needle. In either technique blood is aspired in 

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the cannula as a sign of the needle tip being in the haematoma surrounding the fracture, and the local 
anaestetic is injected(2,3). The haematoma block is traditionally considered to be a safe anaesthetic option 
even with the risk of rapid systemic absorption and a potentially toxic systemic dose of the local 
anaestetic(4,5). It has never been proven superior to other techniques in systematic reviews(6,7), nor has it 
been compared to an ultrasound guided analgesia technique as described in the current protocol. 
2.3 Innervation of the forearm and wrist 
The radial and median nerves innervate the majority of muscles in the forearm and the periosteum of the 
ulna and radius as the posterior and anterior interossus nerves, respectively. Therefore, blocking of these 
nerves at the level of the cubital fossa should alleviate pain and decrease muscular traction allowing 
manipulation of fractures in the radius and ulna(8,9). 
2.4 Distal nerve blocks for procedures on the forearm and hand 
Although blocking the radial, median, and ulnar nerves is not a commonly used form of anaesthesia for closed 
reduction of forearm fractures, it is by no means an experimental anaesthetic procedure. The distal nerve 
blocks of the forearm have long been used both as rescue blocks in case of failed infraclavicular and 
supraclavicular blocks and as a primary choice in the case of surgical procedures involving one or more of the 
nerves innervation areas(10).  
2.5 Properties of lidocaine 
In the present study, lidocaine is our choice of local anaesthetic as it is well-known and widely used. Lidocaine 
and adrenaline in combination has been approved for medical use in Denmark for decades specifically for 
the indications of local infiltration and nerve analgesia(11). Lidocaine is a rapid onset local anaesthetic and in 
combination with adrenaline has an onset time of barely 10 minutes and a duration of at least 120 minutes 
when used for local infiltration and blocking of small nerves(12,13).  
3. Hypothesis and outcome 
3.1 Hypothesis 
We hypothesize that ultrasound guided blocking of the radial and median nerves will improve fracture 
reduction satisfaction for the true Colles’ fractures and improve analgesia for reduction of all fracture types 
compared to the standard haematoma block.  
3.2 Primary outcome 
Reduction satisfaction based on objective X-ray measures according to the National Guideline for Treatment 
of Distal Forearm Fractures. The primary outcome applies for the true Colles’ fractures only. 
3.3 Secondary outcomes 
Will be evaluated for all included fracture types. 
• 
Pain scores using an 11-step numeric rating scale 
• 
Time spent in the Emergency Department 
• 
Secondary fracture dislocation 
 
 

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4 Study design and conduction 
4.1 Selection and enrolment of participants 
4.1.1 Recruitment strategy and screening 
Patients eligible for screening for inclusion are identified in the Emergency Department (ED) at all recruitment 
sites upon primary contact. When an X-ray has revealed the relevant fracture, the ED-staff will call the 
available anaesthesiologist or anaesthesiologist trainee who will perform the inclusion process and 
randomisation. In cases where the anaesthesiologist is unable to perform inclusion due to e.g. lack of time 
or experience a registration of patient data, date and time as well as the reason for the missed inclusion will 
be made.  
In case of randomisation to the control group, the anaesthesiologist/anaesthesiologist trainee will leave the 
ED and take no further part in the treatment or data registration. In case of randomisation to the intervention 
group the anaesthesiologist/anaesthesiologist trainee will perform the ultrasound guided blocks and leave 
the ED before the reduction procedure begins. 
For all included patients a note will be made in the electronic patient journal stating that the patient meets 
all in- and no exclusion criteria, has given an informed consent to participation and received a copy of the 
signed consent form. 
4.1.2 Inclusion criteria 
• 
Presence of a closed distal forearm fracture in need of a closed reduction 
• 
Age > 18 years 
• 
Legally competent 
4.1.3 Exclusion criteria 
• 
Inability to give informed consent 
• 
Allergy or intolerance towards local anaesthetics 
• 
Infection or burns at either injection site 
• 
Multi trauma (defined as other fractures or significant injuries) 
• 
Known pregnancy 
• 
Participation in other studies 
4.1.4 Information and consent 
The anaesthesiologist/anaesthesiologist trainee responsible for inclusion will apply to the national 
regulations regarding informed consent to participation in a clinical trial. Hence, in addition to oral 
information the potential participant will receive written information including both the specific information 
on the current study as well as the general information pamphlet on participant rights when entering a 
clinical trial. All information and inclusion will be carried out by physicians who possess the sufficient 
professional prerequisites to be authorized by the sponsor to have a direct involvement in the project. 
Information will be given in private and the participant will be allowed to have an assessor present. The 
participant and will be given a brief reflection period of approximately 10 minutes before making their 
decision. 
 
 
 

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4.1.5 Participant flow 
The following consort diagram will be continuously filled out to monitor study progress regarding primary 
outcome. 
 
4.1.6 Discontinuation and withdrawal 
Any participant can choose to withdraw from the study at any time. This will have no repercussions on his or 
her right to or quality of continuous treatment. The same applies if a discontinuation is made by the choice 
of the physician. In this case the patient will be informed of the reason for discontinuation. Any withdrawal 
or discontinuation will be noted in the consort diagram and mentioned when presenting results in future 
publications. 
4.2 Randomisation 
4.2.1 General considerations 
Participants will be randomized in either the intervention or the control group using the online randomization 
tool Research Electronic Data Capture (REDCap, Aarhus University, Denmark). 
All patients will receive an intravenous access. Monitoring of heart rate, blood pressure and oxygen 
saturation will be established according to local guidelines at each inclusion site before injection of local 
anaesthetic.  
In both groups, the reduction process will begin 10 minutes after the block has been performed. The 
technique for the actual reduction may vary amongst physicians. To best reflect the clinical practices and to 
avoid the risk of an insufficient reduction due to the physician being forced to comply to a technique 
unfamiliar to him, no further standardisation will be made in this regard. 
4.2.2 Intervention group 
Using a linear probe, the medial and radial nerves will be visualized in the cubital fossa and blocked by 
injection of 5-7 ml lidocaine 20 mg/ml with adrenaline 5 µg/ml (‘SAD’). 

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4.2.3 Control group 
Patients in the control group will receive the standard haematoma block at all inclusion sites. This will be 
performed using the previously described technique and local anaesthetics according to local practices.  
4.3 Blinding 
Only the orthopaedic surgeons evaluating the control X-ray to assess the primary outcome of fracture 
reduction satisfaction will be blinded to randomisation. 
4.4 Data collection 
In both groups, the following will be registered during the treatment period in the emergency department: 
• 
Pain scores using an 11-step numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain 
imaginable) 
o Before local anaesthetics are given 
o During the local anaesthetic procedure 
o During reduction 
• 
Precise amount and type of local anaesthesia used 
• 
In plane/out of plane technique used for the ultrasound guided blocks 
• 
Type and amount of supplementary analgesics/sedatives before and after local anaesthesia 
• 
Fracture classification code 
• 
Treatment plan; conservative vs. operation 
• 
Osteoporosis yes/no 
• 
Patients right/left hand preference 
• 
Patient height and weight 
• 
Any chronic use of opioids 
Following casting of the fracture a control X-ray will be performed and subsequently evaluated independently 
by two skilled orthopaedic surgeons to establish if the reduction was satisfactory. In case of disputes a third 
orthopaedic surgeon will evaluate the X-ray and make a final ruling. The orthopaedic surgeons will further 
determine fracture type. 
In cases where more than one control X-ray is performed due to re-manipulation of the fracture, only the 
first will be evaluated. The fracture will be deemed satisfactory using a binary outcome measure (yes/no) if 
all the following requirements set by the National Clinical Guideline for Treatment of Distal Radius 
Fractures(14) are met: 
• 
< 10-degree dorsal angulation of the radial articular surface 
• 
Ulnar variance < 2 mm 
• 
Discontinuation of the articular line < 2 mm 
• 
No incongruence of the distal radioulnar joint 
Two months after the initial treatment the electronic journal will be evaluated to establish the occurrence 
of secondary dislocation and need for surgery. 
 

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4.5 Data handling 
4.5.1 Data management 
All primary registration of data will be performed on paper by the ED staff. To ensure a simple procedure for 
data collection the registration sheet will be present on a specified location in the ED and each section on 
the sheet marked according to the staff member in charge of each registration.  All registration sheets will 
subsequently be collected by the coordinating investigator and entered online in the REDCap database. 
Access for data registration and access to already submitted data will be granted to all the initiating 
investigators. 
4.5.2 Confidentiality 
All data will be handled in accordance with the act on processing of personal data and no identifiable data 
will be included in the analysis. When the study is concluded all person-sensitive data will be destroyed. 
4.6 Data analysis 
4.6.1 Sample size estimation 
The number of included patients is calculated using data from an unpublished quality database at Viborg 
Regional Hospital. Approximately 15 percent of the true Colles’ fractures are currently being satisfactory 
reduced, and we consider an increase to 30 percent to be clinically relevant. With α = 0.05 and β = 0.8, 121 
patients are needed in each group to detect a statistically significant difference in reduction satisfaction. 
From the same local database we found that the true Colles’ fracture comprises approximately 90 % of the 
total number of fractures and we anticipate a total inclusion of 268 patients (2 x 121 + 10 %). 
4.6.2 Statistics 
Binary data, including primary endpoint will be analysed using chi squared test. For normally distributed 
measurements the differences between groups will be compared using Student´s t-test. Variables considered 
not to be normally distributed will be analysed by Mann-Whitney´s U-test. Two-tailed P-values < 0.05 will be 
considered statistically significant.  
5. Ethical concerns 
5.1 Approvals 
Permission for conduction of the study and gathering of information in the electronic patient journal will be 
received from the Ethical Committee and the Danish Data Protection Agency through the common Regional 
system in the Central Denmark Region. 
We specifically seek permission to access all relevant journal entries in the participants electronic journal 
regarding the current forearm fracture and its treatment from the point of primary contact to the ED and for 
the remainder of the study period. This includes any X-ray information available in different electronic 
systems. 
5.2 Risks and safety considerations 
Regardless of a patient being treated within the study or declined participation, a fracture reduction is 
needed as is analgesia prior to this reduction. As both the haematoma and the ultrasound guided blocks are 
well established methods of analgesia and as lidocaine is well established as a local anaesthetic agent, no 
significant ethical concerns are found with conduction of the study. The establishment of an i.v. access poses 
no significant risks. 

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5.3 Adverse reactions 
Regardless of injecting technique and site the adverse reactions to local anaesthetic use include allergy and 
toxicity. Both are rare when small doses of local anaesthetics are used, as is the case in the current study, 
and most often occur if the local anaestetic is vascularly injected as it increases the risk of rapid systemic 
distribution. Symptoms of toxicity include tinnitus, tingling lips, heart palpitations, altered mental status and 
in extreme cases loss of consciousness, severe heart arrhythmias and cardiac arrest. The intervention group 
is not thought to face a greater risk of adverse effects than the control group, and the ultrasound procedure 
poses no additional risk. As with conduction of all clinical trials, there may be unforeseen risks and adverse 
effects. All patients included in the study are covered by the common patient insurance. 
5.4 Gain and benefits 
Participants have the possible benefit of a reduced pain with regards to both the local anaesthetic and 
reduction procedures as well as the possible gain of a more satisfactory reduction. To our knowledge there 
are no long-term benefits from participation.  The gain for future patients in the potentially increased pain 
relief and reduction satisfaction far outweighs the minimal disadvantages of study participation including 
establishment of an i.v. access and two injection sites when randomized to the intervention group as opposed 
to one, when randomized to the control group or treatment outside the study.  
None of the investigators benefits personally from conducting the study nor from any results and conclusions. 
6. Funding 
All initiative for the current study have been taken by the previously stated physicians. They have no personal 
economic involvement, no possible economic gain from any outcome and no ties to the medical industry or 
corporations gaining from study outcomes.  
Funding for the purchase of iPads for data registration and statistical assistance in the analysis phase will be 
sought from relevant private and public funds. Due to the modest running expenditures comprising only 
lidocaine and injection equipment already present at all inclusion sites the study will be conducted regardless 
of any successful funds applications. 
7. Publication 
Upon approval from all relevant committees the protocol will be made public at clinicaltrials.gov. All results 
and conclusions both positive, negative and inconclusive, drawn from the study will be sought internationally 
published regardless of any discrepancies with our primary hypothesis. 
8. References 
(1) Danish National Patient Registry Database. Available at: 
http://esundhed.dk/sundhedsregistre/LPR/Sider/LPR.aspx. Accessed 04/01, 2017. 
(2) Case RD. Haematoma block--a safe method of reducing Colles' fractures. Injury 1985 July 01;16(7):469-
470. 
(3) Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev 1991 
November 01;20(11):977-979. 
(4) Meinig RP, Quick A, Lobmeyer L. Plasma lidocaine levels following hematoma block for distal radius 
fractures. J Orthop Trauma 1989;3(3):187-191. 

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(5) Quinton DN. Local anaesthetic toxicity of haematoma blocks in manipulation of Colles' fractures. Injury 
1988 July 01;19(4):239-240. 
(6) Frenkel O, Herring AA, Fischer J, Carnell J, Nagdev A. Supracondylar radial nerve block for treatment of 
distal radius fractures in the emergency department. J Emerg Med 2011 October 01;41(4):386-388. 
(7) Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane 
Database Syst Rev 2002;(3)(3):CD003320. 
(8) Atchabahain A, Gupta R. The Anesthesia Guide. New York: McGraw-Hill Education, Lange; 2013. 
(9) Cho H, Lee HY, Gil YC, Choi YR, Yang HJ. Topographical anatomy of the radial nerve and its muscular 
branches related to surface landmarks. Clin Anat 2013 October 01;26(7):862-869. 
(10) Jankovic D, Peng P. Regional Nerve Blocks in Anesthesia and Pain Therapy. Traditional and Ultrasound-
Guided Techniques. Fourth ed. New York: Springer; 2015. 
(11) Danish Medicines Agency. Product Resume 'Lidocaine-adrenaline' SAD. 2015. 
(12) Miller RD. Miller's Anesthesia. Seventh Edition ed.: Churchill Livingstone; 2014. 
(13) Peck TE, Hill SA. Pharmacology for Anaesthesia and Intensive Care. Fourth Edition ed. Cambridge: 
Cambridge University Press; 2014. 
(14) Danish Health Authority. National guideline for the treatment of distal forearm fractures. 2014; 
Available at: 
https://www.sst.dk/da/udgivelser/2014/~/media/EB0328BE70DE4D4AB5C6E164EC87C3BA.ashx?m=.pdf. 
Accessed 05/17, 2017.