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The comparative efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in ultrasound guided infraclavicular block in patients with upper limb fractures: A randomized clinical trial

Protocol summary

Study aim
Comparing the efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in brachial plexus infraclavicular block
Design
A double-blind, randomized phase 2 clinical trial with parallel groups involving 80 patients. We utilized www.Randomization.com for the randomization process.
Settings and conduct
This study will take place in the pain operating room at Shariati Hospital in Tehran, involving 80 patients undergoing upper limb surgery. It is a double-blind, randomized clinical trial. An anesthesia technician, not involved in the study, will prepare the medications outside the operating room. Prefilled syringes will be provided to the anesthesiologist, with all drugs being indistinguishable in color and volume. The surgeon, anesthesiologist, and patients will remain unaware of the administered drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-65; body mass index (BMI) ranging from 20 to 35 kg/m² Exclusion criteria: Requiring more than one fixation in the affected limb; Allergy to opiods, acetaminophen, local anesthetics, NSAIDs; Chronic pain syndrome; Neuromascular disease; Psychological disease; drug abusers (Opiods, alcohol, other illegal drugs);chronic renal and liver disease; Loss of consciousness; pregnancy; infection at the site of procedure; Coagulation disorders or taking anticoagulant agents (except Aspirin)
Intervention groups
Control group: Infraclavicular block under ultrasonophy guide with 30ml bupivacaine 0.5%. Intervention group: Infraclavicular block under ultrasonophy guide with 20ml bupivacaine 0.5% and 10ml lidocaine 2%
Main outcome variables
Onset of complete motor and sensory block; duration of complete motor and sensory block

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250422065437N1
Registration date: 2025-09-16, 1404/06/25
Registration timing: prospective

Last update: 2025-09-16, 1404/06/25
Update count: 0
Registration date
2025-09-16, 1404/06/25
Registrant information
Name
Pouya Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 905 458 2517
Email address
pouyasrf94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in ultrasound guided infraclavicular block in patients with upper limb fractures: A randomized clinical trial
Public title
The comparative efficacy of bupivacaine 0.5% and combination of bupivacaine 0.5% and lidocaine 2% in infraclavicular block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 Body mass index (BMI) ranging from 20 to 35 kg/m² Upper limb fracture
Exclusion criteria:
Requiring more than one fixation in the affected limb Allergy to opioids, acetaminophen, local anesthetics and nsaids Patients with chronic pain syndromes Patients abusing alcohol, opioids ant other anti legal drugs Renal dysfunction (edema, shortness of breath, malaise, hematuria, insomnia) Hepatic dysfunction (jaundice, ascitis, loss of consciousness, malaise, nausa, vomiting) Patients with neuromuscular disease Patients with psychological disease Loss of consciousness Pregnancy Infection at the site of procedure Patients with coagulation disease or taking anti-coagulant agents except Aspirin Reluctance to participation in this study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to either Group A (bupivacaine 0.5%) or Group B (a combination of bupivacaine 0.5% and lidocaine 2%) through the website www.randomization.com. Simple randomization will be conducted at an individualized level. After randomization, the results will be placed in concealed, opaque envelopes. An anesthesiology technician who is not involved in this study and is responsible for drug preparation will open these envelopes. The technician will prepare the drug outside of the operation room and prefilled syringes will be given to anesthesiologist. The prepared drugs are similar in term of the color and volume. The surgeon, patients, and anesthesiologist will remain blinded to the drugs used in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomization, the results will be placed in concealed, opaque envelopes. An anesthesiology technician who is not involved in this study and is responsible for drug preparation will open these envelopes. The technician will prepare the drug outside of the operation room and prefilled syringes will be given to anesthesiologist. The prepared drugs are similar in term of the color and volume. The surgeon, patients, and anesthesiologist will remain blinded to the drugs used in the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Shariati hospital, the intersection of South Kargar street and Jalal-e-Aal-e- Ahmad boulevard
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2024-02-13, 1402/11/24
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1403.117

Health conditions studied

1

Description of health condition studied
Upper limb fractures
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb, level unspecified

Primary outcomes

1

Description
Onset of complete sensory block
Timepoint
Every 1 minute up to 10 minutes, every 2 minutes up to 10 minutes and then every 5 minutes up to 10 minutes or complete anethesia
Method of measurement
Hollman scale with pinprick test

2

Description
Onset of complete motor block
Timepoint
Every 5 minutes up to 30 minutes
Method of measurement
Physical examination of thumb abduction (radial nerve), third finger flexion (median nerve), fifth finger flexion (ulnar nerve) and elbow flexion (musculocutaneous)

Secondary outcomes

1

Description
Duration of sensory block
Timepoint
Every 5 minutes after the onset of complete sensory block
Method of measurement
Time between the onset of complete sensory block to first sensation of pain or patient request for painkillers.

2

Description
Duration of motor block
Timepoint
Every 5 minutes after the onset of complete motor block
Method of measurement
Time between the onset of complete motor block to return of finger functions (Grade 2 in Hollmen Scale)

Intervention groups

1

Description
Control group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% will be injected around the medial, lateral and posterior cords.
Category
Treatment - Other

2

Description
Intervention group: Ultrasonography probe wil be placed medial to coracoid and in a sagittal plane. After visualizing the medial, lateral and posterior cord around the axillary artery, a 18 G, 10Cm needle will be inserted 1 cm medial to coracoid and 10 cm below the clavicle. After infiltration of 1ml Lidocaine 2%, 30 ml of bupivacaine 0.5% in combination with 10 ml of Lidocaine 2% will be injected around the medial, lateral and posterior cords.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Pouya Sharifi
Street address
Shariati hospital, the intersection of South Kargar street and Jalal-e-Aal-e- Ahmad boulevard
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 911 458 2017
Email
pouya.srf94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ahmadreza Jamshidi
Street address
Shariati hospital, the intersection of South Kargar street and Jalal-e-Aal-e- Ahmad boulevard
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 911 458 2017
Email
pouya.srf94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pouya Sharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 6, Mokhtari avenue, Khojastepoor street, Bagh Feiz
City
Tehran
Province
Tehran
Postal code
1114713135
Phone
+98 905 458 2517
Fax
Email
pouyasrf94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pouya Sharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 6, Mokhtari avenue, Khojastepoor street, Bagh Feiz
City
Tehran
Province
Tehran
Postal code
11114713135
Phone
+98 905 458 2517
Fax
Email
pouyasrf94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pouya Sharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 6, Mokhtari avenue, Khojastepoor street, Bagh Feiz
City
Tehran
Province
Tehran
Postal code
1114713135
Phone
+98 905 458 2517
Fax
Email
pouyasrf94@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
6 months after publication of the paper
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
The analized data can only be used in purpose of designing similar studies or review articles.
From where data/document is obtainable
Dr Pouya Sharifi; 00989114582017 pouya.srf94@gmail.com
What processes are involved for a request to access data/document
Please send your request via SMS or Email to Dr Sharifi. The information will be available in 1 or 2 weeks.
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