The main aim of this study is to compare the two methods of spinal block and posterior peripheral ankle block on the pain scale, sleep pattern, and function among patients after hallux valgus deformity surgery.
Design
Two arms parallel-group randomised trial with blinded postoperative care and outcome assessment . Patients are categorized in groups based on randomization blocks.
Settings and conduct
Patients undergo spinal anesthesia after surgery routinely. In this study, people will either have the spinal block or be randomly divided into a group that will have both a spinal block and an ankle peripheral block at the same time. The person who performs postoperative measurements and the patients themselves are blind to study.
Participants/Inclusion and exclusion criteria
Patients in the age groups of 20 to 60 years.Exclusion criteria: People under 20 years of age, congenital deformity, Osteoporosis, patients with bilateral involvement, and patients with cardiopulmonary diseases.
Intervention groups
Two groups of 30 people and the first group is placed under the posterior tibial block at the same time and the second group has only a spinal block.
Main outcome variables
Pain, fentanyl dosage and sleep status of patients during 24 hours after surgery and AOFAS score for the performance after 2 weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047569N1
Registration date:2021-09-23, 1400/07/01
Registration timing:registered_while_recruiting
Last update:2021-09-23, 1400/07/01
Update count:0
Registration date
2021-09-23, 1400/07/01
Registrant information
Name
Amir Sabaghzadeh irani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2204 6857
Email address
dramirsabbaghzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of tibialis posterior nerve block on postoperative pain and functional outcomes of patients undergoing hallux valgus surgery
Public title
effect of posterior tibial nerve block on hallux valgus surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20-65
no other previous surgery of foot
no rheumatologic disease
Lack of sensitivity to anesthetic drugs
hallux valgus deformity moderate to severe
Random allocation of patients will be based on simple randomization and with the help of accepted methods of random sequence production based on the web. The randomizer.org site will be used by filling in the information on the number of patients, two target groups, assigning an equal number in each group, and selecting non-duplicate numbers in this plan. Based on the random sequence numbers generated at the site, patients will be divided into two groups of 30 people under intervention (A) and 30 people in the "Spinal Block" control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
patient do not know that if the anesthetic agent is injected for them in ankle joint and the outcome assessment is done by a person who does not know about the injected drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Beheshti University of Medical Sciences
6,12,24 hours after hallux valgus deformity surgery
Method of measurement
VAS ( visual analogue score )
2
Description
Fentanyl intake every 6 hours after hallux valgus surgery
Timepoint
6,12,24 hours after hallux valgus deformity surgery
Method of measurement
Based on patient addmission profile in orthopedic ward
3
Description
َAOFAS ( American orthopedic association foot and ankle surgery) score
Timepoint
6,12,24 hours after hallux valgus deformity surgery
Method of measurement
The American Orthopedic Foot and Ankle Score (AOFAS) questionnaire
Secondary outcomes
1
Description
Sleep hours during 24 hours after hallux valgus deformity surgery
Timepoint
During 24 hours after surgery
Method of measurement
Patients record in orthopedic ward
Intervention groups
1
Description
Intervention group: peripheral nerve blockage of posterior tibial concurrent with spinal block of hallux valgus surgery.5 ml bupivacaine 0.5% will be administered to posterior tibial nerve, at medial malleolar level and posterior to pulsation of the posterior tibial artery.
Category
Treatment - Other
2
Description
Control group: Spinal nerve block after hallux valgus deformity surgery