Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department
Phase: NA
Conditions: Forearm Fracture, Radius Fractures, Ulnar Fracture
Sponsor: Ankara Etlik City Hospital

Evalua&on of the Eﬃcacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade 
on Analgesia in Forearm Fractures in the Emergency Department 
 
1. Protocol 
 
Trauma pa(ents cons(tute a signiﬁcant por(on of emergency department visits. Forearm 
fractures are common upper extremity fractures in adult pa(ents. A forearm fracture can 
present as an isolated radius fracture, an isolated ulna fracture, or a double bone radius-ulna 
fracture. Forearm fractures cause severe pain, both due to the fracture itself and during the 
reduc(on process. Pain management is crucial in emergency departments (ED). Therefore, 
mul(modal approaches are available to reduce or eliminate pain during the reduc(on process. 
Procedural seda(on and analgesia (PSA), which is widely used in emergency departments and 
eﬀec(vely reduces pain, is par(cularly common. However, recent literature suggests the use 
of peripheral regional block techniques over the use of mul(ple nonsteroidal an(-
inﬂammatory and/or opioid analgesics for pain pallia(on. 
The aim of our study is to evaluate the success of reduc(on and pain pallia(on during the 
reduc(on process in pa(ents with forearm fractures using PSA and ultrasound-guided 
infraclavicular nerve block (ICB). The secondary aim is to compare pa(ent comfort, physician 
comfort, side eﬀects, length of stay in the emergency department, and the need for pain 
medica(on aOer discharge between these two procedures, and to determine the most 
appropriate method. With this study, we aim to contribute to prac(cal applica(ons for 
achieving op(mal pain control in pa(ents with forearm fractures in emergency department 
seQngs. 
PSA (Procedural Seda(on and Analgesia) refers to the suppression of a pa(ent's consciousness 
to maintain vital heart and lung func(ons while using seda(ve and dissocia(ve agents 
combined with analgesics during a medical procedure, with the goal of preven(ng or 
minimizing the pa(ent's awareness, response, and memory of the event. However, the use of 
sedoanalgesic drugs carries signiﬁcant risks, such as respiratory depression or hypotension, 
and requires that every pa(ent be monitored and observed at least un(l they return to a pre-
seda(on level of alertness. The need for the pa(ent to stay in the emergency department for 
at least two hours and the requirement for staﬀ to monitor the pa(ent during this (me present 
certain disadvantages, par(cularly in busy emergency departments. These concerns have led 
to the explora(on of alterna(ve approaches. 

 
Ultrasound (US)-guided peripheral nerve blocks are alterna(ves used in pain management 
during the reduc(on of forearm fractures. These techniques are widely used in outpa(ent 
seQngs, orthopedic surgeries, and postopera(ve pain management in opera(ng rooms. 
Peripheral nerve blocks involve the use of local anesthe(cs and are deﬁned as the inﬁltra(on 
of peripheral nerves with local anesthe(c agents to reduce motor output and sensory input. 
Nerve blocks are eﬀec(ve in pain control, act quickly, have low complica(on rates, and do not 
require prolonged observa(on. As a result, the use of peripheral nerve blocks in pain 
management is increasing in emergency departments. 
Pa(ents presen(ng with forearm fractures to the emergency department will be included in 
the study. The need for reduc(on at the (me of presenta(on will be determined by orthopedic 
doctors. Pa(ents who require reduc(on and have an ASA classiﬁca(on of ASA 1-2 (ASA: 
American Society of Anesthesiologists, Table-1) will be included in the study and followed up. 
The pa(ents will be randomly divided into two groups: Group P, where reduc(on will be 
performed under Procedural Seda(on and Analgesia (PSA), and Group B, where reduc(on will 
be performed under ultrasound-guided infraclavicular nerve block (ICB). Randomiza(on will 
be done by assigning the ﬁrst 5 pa(ents to Group P and the next 5 pa(ents to Group B (the 
procedures are described in detail below), and the following parameters will be evaluated: 
 
Pain levels at the (me of arrival, post-procedure but before reduc(on, and aOer reduc(on will 
be recorded using the Numeric Ra(ng Scale (NRS). (NRS ranges from 0-10, with 0 represen(ng 
no pain and 10 represen(ng unbearable pain.) 
The success of the reduc(on procedure will be assessed, no(ng whether addi(onal reduc(on 
procedures were required, and the ﬁndings on control X-rays aOer each reduc(on (radial 
height, radial inclina(on, and volar (lt) will be recorded and evaluated by orthopedic doctors. 
The length of stay in the emergency department will be recorded as the (me from the pa(ent's 
arrival to discharge. 
Side eﬀects/complica(ons during the procedures will be recorded. 
The need for rescue treatment during the procedure will be evaluated. If the NRS is above 5, 
the ﬁrst-line rescue analgesic treatment will be 50 or 100 mg of tramadol IV, administered in 
100 cc of normal saline over 15 minutes. If the pain remains above NRS 5, the second-line 

treatment will be 50 mcg of fentanyl IV, administered in 100 cc of normal saline over 15 
minutes. 
The need for pain medica(on within 24 hours aOer discharge will be assessed by calling the 
pa(ents. 
Pa(ent sa(sfac(on will be recorded using a 5-point Likert scale (1: very poor, 2: poor, 3: fair, 4: 
good, 5: very good). 
The same sa(sfac(on survey will be administered to the orthopedic doctors who performed 
the reduc(on. 
Procedures for the groups will be as follows before reduc(on: The PSA protocol for Group P 
will be performed by experienced emergency physicians who are skilled in seda(on analgesia, 
advanced life support, and advanced airway management. The pa(ent will be monitored by 
an experienced doctor or nurse during the seda(on period un(l recovery. Emergency 
equipment will be readily available in case of any complica(ons. The PSA protocol will include 
IV ketamine administered at a dose of 1-2 mg/kg. If the NRS remains above 5, addi(onal doses 
of 0.25-1 mg/kg may be repeated every 5 to 10 minutes as needed. The decision to discharge 
the pa(ent will be based on the modiﬁed Aldrete score, one of the recovery scoring systems. 
The ultrasound (US)-gu4ded 4nfraclav4cular nerve block protocol for Group B: The 
4nfraclav4cular block (ICB) 4s a per4pheral nerve block that anesthet4zes the brach4al plexus at 
the level of the cords. ICBs are used for anesthes4a and/or analges4a dur4ng surg4cal or 
procedural 4ntervent4ons on the forearm, wr4st, hand, and f4ngers. The block w4ll be appl4ed 
under ultrasound gu4dance as follows: The pat4ent w4ll be placed 4n a sup4ne pos4t4on, an 
4ntravenous (IV) l4ne w4ll be establ4shed, and the pat4ent w4ll be mon4tored. The pat4ent's head 
w4ll be turned to the s4de oppos4te the block s4te. The arm to be blocked w4ll be adducted and 
placed 4n flex4on across the pat4ent's chest. After the block s4te 4s d4s4nfected w4th pov4done-
4od4ne, a ster4le l4near ultrasound probe (the LOGIQ P9 ultrasound dev4ce currently used 4n our 
emergency department) w4ll be placed long4tud4nally at the recommended s4te for the 
4nfraclav4cular block . Once the ax4llary artery, ve4n, and the cords of the brach4al plexus are 
v4sual4zed, a 22-gauge needle w4ll be advanced 4n-plane w4th the ultrasound probe toward the 
6-7 o'clock pos4t4on relat4ve to the artery. The lateral, med4al, and poster4or cords, conta4n4ng 
hypoecho4c nerve fasc4cles ("honeycomb" appearance), w4ll be 4dent4f4ed. F4rst, 2 mL of sal4ne 
w4ll be 4njected; 4f the spread 4s appropr4ate, the local anesthet4c (LA) solut4on, prepared by 
d4lut4ng 10 mL of 0.5% bup4vaca4ne w4th 10 mL of normal sal4ne to create 20 mL of 0.25% 
bup4vaca4ne, w4ll be 4njected 4n fract4onal doses w4th 4nterm4ttent negat4ve asp4rat4on. The 

spread of the local anesthet4c w4th4n the brach4al plexus w4ll be observed as an expand4ng 
hypoecho4c collect4on w4th4n the plexus. F4fteen m4nutes after th4s procedure, the level of 
anesthes4a w4ll be assessed us4ng a cold-hot test, and reduct4on and cast4ng w4ll be performed 
 
Inclus'on Cr'ter'a: 
Age 18 years and older 
D4agnosed w4th a forearm fracture us4ng standard rad4ography 
Hemodynam4cally stable 
No vascular or nerve 4njury 
No 4nfect4on 4n the sk4n or t4ssues where the needle w4ll pass 
Able to g4ve wr4tten and verbal consent 
 
Exclus'on Cr'ter'a: 
Allergy to drugs used for sedat4on analges4a and per4pheral nerve block 
Hemodynam4cally unstable 
Pat4ents w4th ASA 3-4 class4f4cat4on (for those 4n the PSA group) 
Coagulopathy, l4ver or k4dney fa4lure 
Pat4ents w4th op4o4d, alcohol, or substance abuse 
Sk4n 4nfect4on or open wound at the s4te where local anesthet4c w4ll be appl4ed 
Pregnant or suspected of be4ng pregnant 
Those who do not g4ve wr4tten and verbal consent 
 
Sample S'ze: For the planned analyses 4n th4s study, the sample s4ze calculat4on was based on 
the study by Tek4n et al. t4tled 'Can ultrasound-gu4ded 4nfraclav4cular block be an alternat4ve 
opt4on for forearm reduct4on 4n the emergency department? A prospect4ve random4zed study.' 
In that study, a 30% d4fference between the two groups was found to be s4gn4f4cant, and thus, 
th4s art4cle was used as a reference for our study. Based on th4s reference art4cle, w4th an effect 
s4ze of 0.5 (med4um), an α level of 0.05, and a power of 0.80, 4t was determ4ned that a total of 
78 part4c4pants (39 4n each group) would be suff4c4ent. The sample s4ze analys4s was conducted 
us4ng the GPower 3.1 program. 
 
 
 

Volunteer recru4tment for the study w4ll be term4nated once the total of 78 pat4ents, as 
determ4ned by the power analys4s, 4s reached. 
 
The study rece4ved approval from the Ankara Etl4k C4ty Hosp4tal Eth4cs Comm4ttee on Apr4l 
24, 2024 (approval code: AEŞH-EK1-2024-0040). However, pat4ent recru4tment has not yet 
started. 
Volunteer Recru'tment Start: September 1, 2024 [Expected] 
Pr'mary Complet'on: June 1, 2025 [Expected] 
Study Complet'on: December 1, 2025 [Expected] 
 
 
2. Stat'st'cal analys's  
Stat4st4cal analys4s w4ll be performed us4ng the SPSS 23.0 stat4st4cal software package. In the 
descr4pt4ve f4nd4ngs sect4on, categor4cal var4ables w4ll be presented as numbers and 
percentages, wh4le cont4nuous var4ables w4ll be presented as mean ± standard dev4at4on for 
normally d4str4buted data and as med4an (m4n4mum, max4mum) for non-normally d4str4buted 
data. The normal4ty of the d4str4but4on of cont4nuous var4ables w4ll be assessed us4ng the 
Kolmogorov-Sm4rnov test. Compar4sons between groups for categor4cal var4ables w4ll be 
evaluated us4ng the ch4-square test. For normally d4str4buted quant4tat4ve var4ables, 
compar4sons between the three groups w4ll be made us4ng the ANOVA test. For non-normally 
d4str4buted quant4tat4ve var4ables, the Kruskal-Wall4s test w4ll be used. A p-value of < 0.05 w4ll 
be cons4dered stat4st4cally s4gn4f4cant 4n th4s study 
 
 
3. Informed Consent Form for Volunteers 
Dear Volunteer, 
In our Emergency Department, we are conducting an academic study titled "Evaluation of the 
Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Block on Analgesia in Forearm 
Fractures in the Emergency Department," led by Dr. Emine Sarcan. The study aims to reduce 
pain in adult patients presenting to the emergency department with forearm fractures and to 
reposition displaced fractures without the need for surgery, using sedoanalgesia (mild sedation 
and pain relief) and regional anesthetic procedures. The objective is to assess the advantages of 

these procedures, their effects on pain, the status of regional anesthesia, length of hospital stay, 
and the need for analgesics within 24 hours after discharge. The treatment to be applied during 
the initial presentation to the Emergency Department will be decided by your responsible 
physician. Patients will be divided into two groups: the first 5 patients will be assigned to Group 
P, and the other 5 patients will be assigned to Group B. 
Patients in Group P will undergo procedural sedoanalgesia (PSA). PSA is defined as a state in 
which the patient's consciousness is suppressed, while maintaining vital heart and lung 
functions, to prevent or minimize the patient's awareness, response, and memory of the event 
during a medical procedure. Here, an intravenous line will be established, and the patient will 
receive 1-2 mg/kg of ketamine intravenously. The procedure will be performed when the patient 
is approximately asleep, and the patient will be monitored by the emergency doctor until fully 
awake. 
Patients in Group B will receive a regional anesthesia called an infraclavicular block to reduce 
pain in the affected area. The block procedure will be performed under ultrasound guidance, 
inserting a 22 Gauge needle into the area around the fractured clavicle on the affected side, and 
0.5% bupivacaine, a local anesthetic, will be administered. The procedure will be carried out 
after the forearm becomes numb. Before, during, and after the procedure, you will be asked to 
evaluate your pain on a numeric pain scale (0: no pain, 10: unbearable pain). No additional time 
is required to perform this study, and you will not be subjected to an experimental procedure. 
During the procedure, there may be mild pain and minimal bleeding at the injection site. If you 
continue to experience pain during the procedure, tramadol 50 or 100 mg IV in 100 cc of normal 
saline will be administered as a first-line treatment over 15 minutes. If pain persists, the second-
line treatment of 50 mcg fentanyl in 100 cc of normal saline will be given over 15 minutes 
intravenously. In case of any harm related to the research, the treatment and associated expenses 
will be covered by the responsible investigator, Dr. Emine Sarcan. Any developments during 
the research that may concern you will be promptly communicated to you or your legal 
representative. For additional information about the study or for any concerns regarding 
unwanted effects or other discomforts related to the study, you can contact Dr. Emine Sarcan 
at 0541-625-8585. 

You may refuse to participate in this study. Participation in this research is entirely voluntary, 
and declining to participate will not result in any changes to the treatment provided to you. 
Furthermore, you have the right to withdraw your consent at any stage of the study. 
II- Information on the Rights of the Volunteer 
Dr. Emine Sarcan has informed me that a medical study will be conducted at the Emergency 
Medicine Clinic of Ankara Etlik City Hospital. I have been provided with the above information 
regarding this research and have been invited to participate as a "volunteer." 
If I participate in this research, I believe that my personal information, which should remain 
confidential between me and the physician, will be treated with great care and respect during 
the study. I have been assured that my personal information will be meticulously protected 
when the research results are used for educational and scientific purposes. 
I may withdraw from the study at any time without providing any reason. (However, I am aware 
that it would be appropriate to notify in advance if I decide to withdraw from the research to 
avoid putting the researchers in a difficult position.) Additionally, I can be excluded from the 
study by the researcher, provided that it does not cause any harm to my medical condition. I do 
not incur any financial responsibility for the expenses related to the research. No payment will 
be made to me. I am not obliged to participate in this research, and I may choose not to 
participate. I have not faced any coercion to join the study. If I refuse to participate, I understand 
that this will not affect my medical care or my relationship with the physician. I have 
comprehended all the explanations given to me in detail. After taking a certain time to think 
independently, I have decided to participate as a "volunteer" in this research project. I accept 
this invitation with great satisfaction and willingness. 
A copy of this signed form will be given to me. 
Participant's Name and Surname:  
Signature: 
Witness's Name and Surname:  
Signature: 

Physician Conducting the Interview  
Name, Surname 
Signature: