The main aim of this study is to compare the post-operative analgesic efficacy of thoracic epidural block when compared with erector spinae plane block in patients post-thoracotomies
Design
Randomized controlled trial. Method of randomization was non-probability consecutive by lottery method.
Settings and conduct
Patients were randomized into two groups thoracic epidural block (Group T) and erector spinae group (Group E) an informed written consent was taken .Standard monitoring was attached in both groups .
After securing IV line and preparing patient patient in Group T were placed in sitting position and 18G tuohy needle was passed for catheter in T3-6 epidural space .In Erector Spinae Group patoent were placed in semi lateral position and block was performed as per NYSORA guidelines and 20G catheter placed in situ for infusion in next 24 person ours.
Participants/Inclusion and exclusion criteria
Inclusion Criteria included all male and female patients between ages 25-75 years presenting in the operating room for elective thoracotomies.
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 percent after supplemental oxygen or patients unwilling to be included in the trial.
Intervention groups
Patients were divided into two interventional groups thoracic epidural block group (Group T) (n=20) and erector spinae block group (Group E) (n=20).
Main outcome variables
Mean time to first dose analgesia
Total dose of intravenous analgesia needed in 24 hours
Median pain scores at 1,3,6,12 and 24 hours
Patient satisfaction Score for pain relief in 24 hours
General information
Reason for update
Acronym
ESP (Erector Spinae Block)
IRCT registration information
IRCT registration number:IRCT20231113060036N1
Registration date:2024-02-07, 1402/11/18
Registration timing:registered_while_recruiting
Last update:2024-02-07, 1402/11/18
Update count:0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Sikander Hayat
Name of organization / entity
National university of medical sciences rawalpindi
Country
Pakistan
Phone
+92 346 6582936
Email address
sikanderhayat94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-02-10, 1402/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of thoracic epidural block versus erector spinae plane block for post operative pain relief in thoracotomies
Public title
Comparison of Thoracic Epidural Block versus Erector Spinae Plane Block for post operative pain relief in thoracotomies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male and Female patients between ages 25-75 years
Presenting in operating room for thoracotomies
Exclusion criteria:
Patients with metastatic disease
Major cardiac or respiratory disease
Low ejection fraction
Post chemotherapy
Allergy to lignocaine or bupivacaine
Patients with advanced polytrauma causing haemodynamic instability
Patients with oxygen saturation less than 92 percent
Patients unwilling to be included in trial
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization was non probability consecutive by lottery method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Combined Military Hospital Rawalpindi
Street address
CMH Road Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
494
Health conditions studied
1
Description of health condition studied
Comparison of Pain relief in patients with thoractimies post operatively using erector spinae and epidural block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Median pain scores, Mean time to first rescue analgesia, total dose of intravenous analgesia needed in 24 hours, patient satisfaction for pain relief
Timepoint
Median pain scores at 1, 3,6, 12 and 24 hours, total intravenous analgesia needed in 24 hours after intervention, patient satifaction score 24 hours after intervention
Method of measurement
Visual analogue Score, patient satisfaction score on a 7 point likert scale. Total dose of analgesia in milligram
Secondary outcomes
1
Description
Nausea/Vomiting, hypotension and sedation
Timepoint
24 hours after intervention
Method of measurement
Number of episodes of vomiting,Manometry, GCS
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
2
Description
Intervention group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rawalpindi Punjab Pakistan
Full name of responsible person
Sikander Hayat
Street address
House No. 6054/18-B Rose lane 09 New Lalazaar
City
Rawalpindi
Postal code
46600
Phone
+92 346 6582936
Email
Sikanderhayat94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Kamran Ahmed
Street address
CMH Road Rawalpindi
City
Rawalpindi
Postal code
46600
Phone
+92 315 5270944
Email
kahmed72462@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi
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
National University of Medical Sciences
Full name of responsible person
Ali Raza
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House No.6054/18-B rose lane 09 New lalazaar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46600
Phone
+92 304 4805098
Email
Aliraza54@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
National University of Medical Sciences Rawalpindi
Full name of responsible person
Atta Amin
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
AMC Mess Abid Majeed Road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46600
Phone
+92 300 9559851
Email
attaamin64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
National university of Medical Sciences
Full name of responsible person
Sikander Hayat
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House No.6054/18-B Rose lane 09 New Lalazaar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46600
Phone
+92 346 6582936
Email
sikanderhayat94@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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