To compare the sensory, motor, block duration and added analgesia requirements between ultrasound guided femoropopliteal block and spinal anesthesia in patients with malleolar fractures of the ankle.
Design
A randomized control trial was carried out at the Department of anesthesiology. A pilot study was carried out before the start of the trial with 15 participants in each group, one to receive spinal anesthesia and the other to be administered femoropopliteal block under ultrasound guidance for malleolar fracture of the ankle.
Settings and conduct
The method of randomization was non-probability consecutive sampling by lottery method.
Participants/Inclusion and exclusion criteria
Included all ASA-I and II male and female patients between ages 25-55 years.
Excluded patients with major cardiac or respiratory disease, patients with failed spinal or femoropopliteal block after three unsuccessful attempts, patients allergic to local anesthetic including bupivacaine, lignocaine and steroids including dexamethasone, patients with malignancy or malignant disease, pregnant females and patients unwilling to be included in the study.
Intervention groups
The trial randomized all patients as per the inclusion criteria furnished. The patients were divided into the spinal group and the femoropopliteal block group. Once the patients were divided into the two groups, an informed written consent was taken, and patients in both groups were explained in detail about the procedure and possible complications. Standard monitoring including non-invasive blood pressure, heart rate, capnography and ECG were attached to participants in both groups.
Main outcome variables
Duration of surgery.
Mean time to onset of sensory block.
Mean time to onset of motor block.
Mean time to first dose rescue analgesia.
Mean time of analgesia given in HDU.
Mean HDU stay.
Mean patient satisfaction score for pain releif.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231211060337N1
Registration date:2024-01-08, 1402/10/18
Registration timing:registered_while_recruiting
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Afzal Shabbir
Name of organization / entity
Armed Force Postgraduate Medical Institute (AFPGMI)
Country
Pakistan
Phone
+92 313 5158969
Email address
afzalshabbir68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-16, 1402/05/25
Expected recruitment end date
2024-02-15, 1402/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasound guided femoropopliteal block versus spinal anesthesia for ankle surgery
Public title
Comparison of ultrasound guided femoropopliteal block versus spinal anesthesia for ankle surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all ASA-I and II male and female patients between ages 25-55 years presenting for surgical fixation of malleolar fracture of the ankle.
Exclusion criteria:
Included patients with major cardiac or respiratory disease, patients with failed spinal or femoropopliteal block after three unsuccessful attempts.
Patients allergic to local anesthetics including bupivacaine , lignocaine and steroids including dexamethasone.
Patients with malignancy or metastatic disease, pregnant females and patients unwilling to be included in the study
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
More than 1 sample in each individual
Number of samples in each individual:
1
1
Randomization (investigator's opinion)
Randomized
Randomization description
The trail randomized all patients as per the inclusion criteria furnished. The patients were divided into the spinal group and the femoropopliteal block group. Once the patients were divided into the two groups, an informed written consent was taken, and patients in both groups were explained in detail about the procedure and possible complications. Standards monitoring including non-invasive blood pressure, heart rate, capnography and ECG were attached to participants in both groups.
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 comiittee of combined military hospital
Street address
Tamizudin road , lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
CMH/RWP
Health conditions studied
1
Description of health condition studied
Ankle surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
We conclude that spinal anesthesia provides early sensory and motor onset but femoropopliteal block is superior when comparing block duration and total dose of analgesia needed in 24 hours post-operatively.
Timepoint
24 hours post operative
Method of measurement
By measuring the logevity of the block
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Spinal anesthesia was administered in Group S using a standard 27 G Braun spinal needle in the L3-L4 spinal space under strict aseptic measures by a consultant anesthetist and 0.5% hyperbaric bupivacaine using a volume of 2.5 ml was administered. Onset and quality of sensory and motor block was checked and re-assessed every 2 minutes using the modified Bromage scale for motor and cold spray method for check for sensory block integrity until an effective sensory level was achieved for spinal dermatomal level T12 and below and motor block effectiveness with a Bromage score of 1.
Category
Treatment - Other
2
Description
Control group: Patient in the femoropopliteal block group were administered the block in prone position for the popliteal block blocking the tibial and common peroneal nerves in the popliteal space using 15ml of 0.5%bupivacaine with 2mg dexamethasone. Patients were then turned supine and 5ml of 0.5%bupivacaine with 0.5mg dexamethasone was administered in the femoral sheath for the femoral block. Both the blocks were performed under strict aseptic measures by a consultant pain specialist following standard guidelines furnished by NYSORA. Onset of the block was checked and re-assessed every two minutes until sensory and motor blocks were achieved as in the spinal group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military hospital
Full name of responsible person
Afzal shabbir
Street address
H2JW+9V8, CMH Rd, Rawalpindi, Punjab
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
afzalshabbir68@gamil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr khalid buland
Street address
Tamizudin road , lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
afzalshabbir68@gamil.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
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
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Afzal shabbir
Position
Registrar Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gamil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Afzal shabbir
Position
Registrar Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gamil.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Afzal shabbir
Position
Registrar Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gamil.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