The aim of this study is to compare the per and post-operative analgesic efficacy and adverse effect profile of ultrasound guided paravertebral plane block versus epidural anesthesia in patients with bronchiectasis planned for partial pneumonectomy.
Design
Parallel group, single center, interventional randomized controlled trial
Settings and conduct
Done at Combined Military Hospital, Rawalpindi
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA-II and III patients between ages 60-70 years presenting in the thoracic surgical department for partial pneumectomy for bronchiectasis.
Exclusion criteria included patients with major cardiac or respiratory disease, low ejection fraction, allergy to bupivacaine or nalbuphine, unwilling to be included in the study, infection at site of block, coagulation disorders or spine deformity or having contraindication to epidural insertion.
Intervention groups
The patients will be divided into the paravertebral group (PVB) (n=45) and epidural group (n=45). The method of sampling was non-probability consecutive sampling via lottery method.
Patients in the paravertebral group (PVB) were taken to the procedure room before starting the procedure. Paravertebral block was given in sitting position with the arms of the patient extended. Confirmation correct needle placement was done by deflection of the pleura downwards on injecting 2 mL of saline.
Patient in the epidural group were prepped for procedure and 18 G epidural catheter after priming was inserted in the T8 vertebral space.
Main outcome variables
Primary variables measured were per-operative analgesia requirement, patient satisfaction for pain relief 24 hours after surgery and 24- hour total dose of analgesia needed. Secondary variables observed were hypotension, nausea, shivering and respiratory depression.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230812059125N1
Registration date:2023-08-22, 1402/05/31
Registration timing:registered_while_recruiting
Last update:2023-08-22, 1402/05/31
Update count:0
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
Saad Hameed
Name of organization / entity
Combined Military Hospital (CMH) Rawalpindi
Country
Pakistan
Phone
+92 943 412591
Email address
saadhameed_bhatti@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISON OF PARAVERTEBRAL BLOCK (PVB) VERSUS EPIDURAL ANESTHESIA IN PARTIAL PNEUMONECTOMY FOR BRONCHIECTASIS IN THE GERIATRIC AGE GROUP
Public title
PVB VERSUS EPIDURAL FOR PAIN RELIEF IN PNEUMECTOMY PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all ASA-II and III patients between ages 60-70 years presenting in the thoracic surgical department for partial pneumectomy for bronchiectasis
Exclusion criteria:
Major cardiac or respiratory disease
Low ejection fraction
Infection at block site
Coagulation disorders
Allergic to bupivacaine or nalbuphine
Unwilling to be included in the study
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into the PVB group and the Epidural group by non-probability consecutive sampling by lottery method
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 Rawalpindi
Street address
CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
ERB#267
Health conditions studied
1
Description of health condition studied
Analgesic efficacy of regional block in geriatric patients with bronchiectasis
ICD-10 code
J47
ICD-10 code description
Bronchiectasis
Primary outcomes
1
Description
Primary variables measured were per-operative analgesia requirement, patient satisfaction for pain relief 24 hours after surgery and 24- hour total dose of analgesia needed after the block
Timepoint
Pain relief and total analgesia needed after the block intervention for 24 hours
Method of measurement
Total dose of analgesia needed by adding doses from the proforma and pain score by the stadard visual analog scale
Secondary outcomes
1
Description
Secondary variables observed were hypotension, nausea, shivering and respiratory depression.
Timepoint
For 24 hours after block administration
Method of measurement
Frequency of symptoms as noted by the resident anesthetist on duty in the high dependency unit
Intervention groups
1
Description
Intervention group 1: Paravertebral block block group (PVB)
Category
Treatment - Other
2
Description
Intervention group 2: Epidural anesthesia group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital (CMH) Rawalpindi
Full name of responsible person
Dr. Saad Hameed
Street address
CMH Rwp
City
Rawalpindi
Postal code
46000
Phone
+92 321 5420669
Email
saadhameed_bhatti@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Rwp
Full name of responsible person
Dr. Saad Hameed Bhatti
Street address
CMH Rwp
City
Rawalpindi
Postal code
46000
Phone
+92 321 5420669
Email
saadhameed_bhatti@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Rwp
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital (CMH) Rawalpindi
Full name of responsible person
Saad Hameed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
OT complex CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 943 412591
Fax
Email
saadhameed_bhatti@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital (CMH) Rawalpindi
Full name of responsible person
Saad Hameed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
OT complex CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 943 412591
Fax
Email
saadhameed_bhatti@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital (CMH) Rawalpindi
Full name of responsible person
Saad Hameed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
OT complex CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 943 412591
Fax
Email
saadhameed_bhatti@hotmail.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
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
Original mauscript along with complete study data set and SPSS output sheets
When the data will become available and for how long
After approval of the mauscript for publication by a journal
To whom data/document is available
All medical academics including students and consultants
Under which criteria data/document could be used
Can be used as reference for academic purposes after permission of original author
From where data/document is obtainable
Will be shared online through cloud sharing after approval by author
What processes are involved for a request to access data/document
Formal email to the author requesting permission and how it would be used