Determining the effect of enhanced recovery after surgery protocols on mobility time after spinal surgery
Design
Clinical trial with control group, parallel group, randomized 80 patients40 patients in the control group and 40 patients in the ERAS group
Settings and conduct
This trial will be conducted on patients who undergo elective spinal surgery, Shariati Hospital,Tehran,Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:≥ 18 years of age and maximum 80
Class 1 to 2 ASA anesthesia
Absence of heart failure (EF <20%)
No uncontrolled blood pressure or diabetes
No pregnancy
Do not use opioids or opioid antagonists in 10 days before
Exclusion criteria: Emergent surgery
Patient dissatisfaction with continued participation in the study
Pregnant women
Addict patients
Intervention groups
All patients are monitored under the ASA standard.In the ERAS group, patients will first be given complete oral instruction on the procedure. They will then be provided with an educational pamphlet for further reading. Candidates for surgery who smoke are advised to quit smoking one month before surgery. Patients are allowed to drink carbohydrate drinks the day before surgery up to two hours before surgery. The method of anesthesia will be complete intravenous anesthesia.During surgery, the multi-modal method will be used to perform the drug-free analgesia protocol. To control postoperative pain, 1 gram of acetaminophen is given every 6 hours, and in the case of VAS above 4, a dose of 50 micro fentanil up to VAS reduction is prescribed below 4.In the control group (8 hours of preoperative fasting), the Foley catheter is routinely implanted. Drugs such as fentanyl are used to control pain.
Main outcome variables
Pain control,nausea and vomiting,length of hospital stay after surgery, time of mobilization after surgery in the intervention group compared to the control group based on age,and sex.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052849N1
Registration date:2022-02-01, 1400/11/12
Registration timing:prospective
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Arash Heroabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
aheroabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-05-15, 1401/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the enhance recovery after surgery (ERAS) modality effect on mobilization time after spine surgery
Public title
The effect of enhance recovery after surgery (ERAS) modality on mobilization time after spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
≥ 18 years of age and maximum 80
Class 1 to 2 ASA anesthesia
Absence of heart failure (EF <20%)
No uncontrolled blood pressure or diabetes
No pregnancy
Do not use opioids or opioid antagonists in 10 days before
Exclusion criteria:
Emergent surgery
Patient dissatisfaction with continued participation in the study
Pregnant women
Addict patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individual randomization is used. The sequence of random numbers is generated using "Randomization.com" website with simple randomization method. Finally, the patients are divided into two separate groups by sealed, opaque and sequenced envelopes. Envelopes are no different in size and color. These envelopes, which contain ERAS protocol pamphlets or routine care, are given to the researcher at the clinic. The researcher opens the numbers on the envelope in order for the eligible patients and assigns them to one of the two groups based on the pamphlets and descriptions inside the envelope.
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
Ethics Committee of Tehran University of Medical Sciences, School of Medicine
Street address
Keshavarz Blvd, Qarib street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.129
Health conditions studied
1
Description of health condition studied
Spine surgery
ICD-10 code
S24.2XXD
ICD-10 code description
Injury of nerve root of thoracic spine, subsequent encounter
Primary outcomes
1
Description
Pain score
Timepoint
1,2,6,12 ,24 hours after operation-2 days after surgery
Method of measurement
Visual analog scale (VAS)
2
Description
Nausea and vomiting
Timepoint
1,2,6,12 ,24 hours after operation-2 days after surgery
Method of measurement
Questionnaire and the presence of symptoms
3
Description
Duration of hospitalization after surgery
Timepoint
24, 48, 72 and 96 hours after surgery
Method of measurement
Patient discharge or continued hospitalization
4
Description
Mobility time after surgery
Timepoint
1,2,6,12 ,24 hours after operation-2 days after surgery
Method of measurement
The patient gets out of bed
Secondary outcomes
empty
Intervention groups
1
Description
The control group will be patients who were candidates for elective spinal surgery and will receive a conventional recovery.
Category
Treatment - Drugs
2
Description
The intervention group will be patients who were candidates for elective spinal surgery and will receive an enhanced recovery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Arsh Heroabadi
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
aheroabadi@sina.tims.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8822 1444
Fax
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali Shariati Hospital, Jalal-Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Fax
+98 21 8822 2282
Email
arash.heroabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali shariati Hospital, Jalal-al ahmad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
arash.heroabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati hospital, Jalal Al-ahmad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 1444
Email
arash.heroabadi@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
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
Not all data can be shared.
When the data will become available and for how long
4 months after article publication.
To whom data/document is available
All people
Under which criteria data/document could be used
All analysis are possible on the data.
From where data/document is obtainable
arash.heroabadi@gmail.com
Dr Arash Heroabadi, M.D., Anesthesiologist
What processes are involved for a request to access data/document