The aim of this study is to compare analgesic efficacy and patient satisfaction when comparing the intercostal nerve block versus erector spinae block in patients presenting with traumatic multiple rib fractures.
Design
Randomized controlled trial
Single center randomized interventional study
Settings and conduct
Conducted at Combined Military Hospital (CMH) Gujranwala
Patients in Group E received intravenous 0.5% bupivacaine with 2% lignocaine diluted in distilled water to make a total volume of 20 ml given according to block guidelines under ultrasound guidance furnished by NYSORA. Patients in Group I received the similar titration of drug as 3 ml aliquots in each intercostal space under ultrasound guidance according to block guidelines furnished by NYSORA as well.
Participants/Inclusion and exclusion criteria
Total 380 participants randomized into two groups of 190 each
Inclusion criteria included all male and female patients between ages 25-55 years presenting in the operating room for pain relief with regional block with multiple rib fractures (>2 ribs) not requiring surgical intervention admitted for observation.
Exclusion criteria included patients with metastatic disease, major cardiac or respiratory disease, low ejection fraction, post chemotherapy, allergy to lignocaine or bupivacaine, patients with advanced polytrauma causing hemodynamic instability, patients with oxygen saturation less than 92% after supplemental oxygen, patients with flail chest or pneumothorax and patients unwilling to be included in the study.
Intervention groups
Group E: To receive erector spinae block
Group I: To receive intercostal nerve block
Main outcome variables
Primary variables measured were mean time to first rescue analgesia, total dose of intravenous analgesia needed in 24 hours and patient satisfaction for pain relief on the Likert scale 24 hours after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230822059225N1
Registration date:2023-08-26, 1402/06/04
Registration timing:registered_while_recruiting
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Taimur Afridi
Name of organization / entity
Combined Military Hospital Gujranwala
Country
Pakistan
Phone
+92 346 5051728
Email address
taimurazamafridi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-01, 1402/01/12
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
INTERCOSTAL NERVE BLOCK (INB) VERSUS ERECTOR SPINAE BLOCK (ESP) FOR ANALGESIC EFFICACY IN PATIENTS WITH TRAUMATIC MULTIPLE RIB FRACTURES
Public title
ESP VERSUS INTERCOSTAL NERVE BLOCK FOR PAIN IN RIB FRACTURES
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all male and female patients between ages 25-55 years presenting in the operating room for pain relief with regional block with multiple rib fractures (>2 ribs)
Not requiring surgical intervention for repair
Under observation in the high dependency unit
Exclusion criteria:
Patients with metastatic disease
Major cardiac or respiratory disease, low ejection fraction or post chemotherapy
Allergy to lignocaine or bupivacaine
Patients with advanced polytrauma causing hemodynamic instability
Patients with oxygen saturation less than 92% after supplemental oxygen
Patients with flail chest or pneumothorax
Patients unwilling to be included in the study
Age
From 25 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
380
Randomization (investigator's opinion)
Randomized
Randomization description
Minimum sample size came out to be 365 patients after using the WHO calculator keeping the confidence interval at 95%, margin of error at 5%. We included 380 patients in our study according to the inclusion criteria furnished. The method of randomization was non-probability consecutive after lottery method into Group E for ESP block and Group I for Intercostal nerve block intervention (190 patients in each group). Patients were randomly selected through lottery method by chits given to the resident on duty in the operating room and patients designated to each intervention were documented and recorded on an excel sheet for data record.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Board CMH Gujranwala
Street address
Gujranwala Cantt
City
Gujranwala
Postal code
52250
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
CMH-GWA-00100
Health conditions studied
1
Description of health condition studied
Rib fracture
ICD-10 code
S22.4
ICD-10 code description
Multiple fractures of ribs
Primary outcomes
1
Description
Time to first dose of rescue analgesia
Timepoint
24 hours after intervention
Method of measurement
Pain score above 5 on the standard visual analog scale
2
Description
Total dose of analgesia given
Timepoint
In 24 hours after intervention
Method of measurement
Dose charting of intravenous nalbuphine once pain scores above 5 after intervention
3
Description
Patient satisfaction
Timepoint
24 hours after intervention
Method of measurement
Standard 7 point Likert scale
Secondary outcomes
1
Description
Nausea/Vomiting
Timepoint
In 24 hours after intervention
Method of measurement
Frequency of episodes by the resident anesthetist on duty in HDU
2
Description
Hypotension
Timepoint
In 24 hours after intervention
Method of measurement
Systolic BP <80 and Diastolic <60 mmHg monitored and charted hourly
3
Description
Post-procedure sedation
Timepoint
In 24 hours after intervention
Method of measurement
Digital sphygmomanometer
Intervention groups
1
Description
Intervention group: Group E: Erector spinae block group.Patients in Group E received intravenous 0.5% bupivacaine with 2% lignocaine diluted in distilled water to make a total volume of 20 ml given according to block guidelines under ultrasound guidance furnished by NYSORA
Category
Treatment - Drugs
2
Description
Intervention group: Group I: Intercostal nerve block group.Patients in Group I received the similar titration of drug as 3 ml aliquots in each intercostal space under ultrasound guidance according to block guidelines furnished by NYSORA
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital (CMH) Gujranwala
Full name of responsible person
Dr Taimur Azam Khan
Street address
Gujranwala Cantt
City
Gujranwala
Postal code
52250
Phone
+92 346 5051728
Email
taimurazamafridi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Gujranwala
Full name of responsible person
Taimur Azam Afridi
Street address
Gujranwala Cantt
City
Gujranwala
Postal code
52250
Phone
+92 346 5051728
Email
taimurazamafridi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Gujranwala
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital Gujranwala
Full name of responsible person
Taimur Afridi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
CMH Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52250
Phone
+92 346 5051728
Fax
Email
taimurazamafridi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Gujranwala
Full name of responsible person
Taimur Afridi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
CMH Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52250
Phone
+92 346 5051728
Fax
Email
taimurazamafridi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Gujranwala
Full name of responsible person
Taimur Afridi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
CMH Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52250
Phone
+92 346 5051728
Fax
Email
taimurazamafridi@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Article manuscript, data set and output SPSS sheets after approval of article by journal
When the data will become available and for how long
After approval of the manuscript by the journal, data will be available online indefinitely
To whom data/document is available
All academic institutions including residents and consultants for their academic purposes
Under which criteria data/document could be used
For academic purposes
From where data/document is obtainable
Through email after approval from the primary author
Dr. Taimur Azam Afridi
Email: taimurazamafridi@yahoo.com
What processes are involved for a request to access data/document
Request through email to be approved by primary author
Email already provided
Usual scrutiny time from contact through email to grant of permission is approximately 7 days