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Investigating the Effect of Regional Posterior Tibial Nerve Block with First Metatarsophalangeal Joint Capsule on Clinical Performance and Postoperative Analgesia in Hallux Valgus Patients

Protocol summary

Study aim
This study investigates the impact of regional posterior tibial nerve block (PTNB) with first metatarsophalangeal joint capsule on clinical performance and postoperative analgesia in patients undergoing hallux valgus surgery
Design
A randomized controlled clinical trial with parallel groups, single blinded, on 40 patients. Randomization was performed using concealed envelopes
Settings and conduct
A prospective clinical trial study on patients with Hallux Valgus admitted for surgical intervention at Akhtar Hospital. Patients were randomized into two groups. While the intervention group received nerve block cocktail in two anatomical regions, patients in the control group received cocktail in one region and placebo in the second region.
Participants/Inclusion and exclusion criteria
Patients admitted for Hallux Valgus surgery at Akhtar orthopaedic hospital, who signed the informed consent letter were included. Exclusion criteria of the study were severe hallux valgus with metatarsophalangeal angle>40°, patients with neuromuscular movement disorders, respiratory disorders, previous surgery history on the lower limb, sensitivity to anesthetic cocktail solution and Cognitive or language disorders.
Intervention groups
Patients in the intervention group (Group A) received 18 cc of a cocktail solution in both anatomical regions. Patients in the control group (Group B) received 15 cc of cocktail in the first anatomical region, and 3 cc of placebo (normal saline) in the second region.
Main outcome variables
Clinical outcomes were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) and Foot and Ankle Outcome Score (FAOS) at 3, 6, and 12 months post-surgery. Pain levels were measured using the Visual Analog Scale (VAS) at 12, 24, 48, 72, and 96 hours postoperatively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230522058251N3
Registration date: 2024-08-01, 1403/05/11
Registration timing: prospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Mohammad Hossein Mahrooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7709 4257
Email address
mohamad.mahrooz@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Regional Posterior Tibial Nerve Block with First Metatarsophalangeal Joint Capsule on Clinical Performance and Postoperative Analgesia in Hallux Valgus Patients
Public title
Investigating the Effect of Regional Posterior Tibial Nerve Block with First Metatarsophalangeal Joint Capsule on Clinical Performance and Postoperative Analgesia in Hallux Valgus Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted for Hallux Valgus surgery at Akhtar Orthopaedic Hospital in Tehran signed informed consent letter
Exclusion criteria:
severe hallux valgus with metatarsophalangeal angle>40° patients with neuromuscular movement disorders respiratory disorders previous surgery history on the lower limb sensitivity to anesthetic cocktail solution Cognitive or language disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A pool of sealed, opaque envelopes containing a note with either of two phrases, 'Intervention Group' or 'Control Group,' is prepared in advance. Patients randomly chose one of these envelopes, and based on it, are allocated to either one of the two groups: intervention or control
Blinding (investigator's opinion)
Single blinded
Blinding description
Group A was injected in the first and second anatomical region with a specific dose of cocktail (18cc ), and group B was injected in the first anatomical region with 15cc cocktail and the second region with 3cc placebo ( normal saline)
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of medical sciences
Street address
7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1342

Health conditions studied

1

Description of health condition studied
Hallux Valgus
ICD-10 code
M20.1
ICD-10 code description
Hallux valgus (acquired)

Primary outcomes

1

Description
Surgical outcome
Timepoint
3, 6 and 12 months after the surgery
Method of measurement
American Orthopaedic Foot and Ankle Society score

2

Description
surgical outcome
Timepoint
3, 6 and 12 months after surgery
Method of measurement
Foot and Ankle Outcome Score (FAOS)

3

Description
pain in surgical site
Timepoint
12, 24, 48, 72, and 96 hours postoperatively
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The patients underwent ultrasound-guided nerve block in two anatomical regions. The first region was located proximal to the popliteal fossa of the knee, below the bifurcation of the sciatic nerve, near the posterior tibial nerve (where the posterior tibial nerve and common peroneal nerve separate from the sciatic nerve). The second region targeted was the distal part of the posterior tibial nerve in the posteromedial area of the ankle, situated between the Achilles tendon and the medial malleolus, as well as the capsule of the first metatarsophalangeal joint of the foot. Patients in the intervention group (Group A) received 18 cc of a cocktail solution in both anatomical regions.
Category
Treatment - Drugs

2

Description
Control group: The patients underwent ultrasound-guided nerve block in one anatomical regions. The first region was located proximal to the popliteal fossa of the knee, below the bifurcation of the sciatic nerve, near the posterior tibial nerve (where the posterior tibial nerve and common peroneal nerve separate from the sciatic nerve). The second region targeted was the distal part of the posterior tibial nerve in the posteromedial area of the ankle, situated between the Achilles tendon and the medial malleolus, as well as the capsule of the first metatarsophalangeal joint of the foot. Patients in the control group received 15cc of cocktail in the first anatomical region and 3cc of placebo (normal saline) in the second region.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar othopaedic hospital
Full name of responsible person
Morteza Gholipour
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Morteza Gholipour
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Morteza Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
Mortezagholipour25@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Morteza Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
Mortezagholipour25@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
mohamad.mahrooz@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Patients' demographic data including age and sex who were undergone Hallux Valgus surgery, and the preoperative FAOS and AOFAS questionnaires results, as well as pain levels recorded via VAS.
When the data will become available and for how long
Data will be available as soon as the article is published
To whom data/document is available
Researchers in every university, or other scientific research institutes
Under which criteria data/document could be used
The data will be anonymized to ensure patient confidentiality
From where data/document is obtainable
To access data please contact the corresponding author using the contact information included in the published article
What processes are involved for a request to access data/document
The request should be formally submitted in a formal letterhead from the university or research institute as the requesting party for the corresponding author
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