Protocol summary

Study aim
Comparison Between Sublingual Buprenorphine and Fentanyl Intravnous Pump for Postoperative pain relief after open Cholecystectomy Surgery
Design
The present study was a double blind clinical trial, in this study, 80 patients undergoing open Cholecystectomy were randomly divided into two groups and get into the study. the intervention group of Patients receiving Sublingual Buprenorphine Tablet and Placebo Pump and the control group received Placebo and intravenous Fentanyl Pump.
Settings and conduct
Trial will include patients undergoing open Cholecystectomy in Fatemi and Imam Khomeini hospitals in Ardabil city.The study is randomized simple randomized, The drugs were in separate packages and two envelopes and Patients and injectors have no knowledge of the contents of the envelope. In the intervention group, Sublingual Buprenorphine tablet administered 0.4 mg in 6, 12 and 18 hours recovey and placebo pump 50 cc normal saline in recovery and continued for 24 hours, if pain is not controlled, PCA is injected every 15 minutes.In the control group, Placebo Tablets were administered at 6,12 and 18 h,50 cc intravenous Fentanyl Pump (40 cc Fentanyl and 10 cc normal saline) embedded and half a cc (20 micrograms) of stat is injected and if the pain is not controlled, PCA is given by the Patient.then the VRS Score, Nausea, Vomiting, sedation of both groups were evaluated during the study times.
Participants/Inclusion and exclusion criteria
Inclusion criteria:ASA I و II,No other surgery, Age range 20 to 50 years. Exclusion criteria:History of opium and nerve medication use , ASA ≥ 3, Other surgery concurrent and complicated.
Intervention groups
Administration of Sublingual Buprenorphine and Placebo Pump to the intervention group,Administration of Placebo and Fentanyl Pump to control group.
Main outcome variables
Reduction of pain after open Cholecystectomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190901044665N1
Registration date: 2019-10-30, 1398/08/08
Registration timing: registered_while_recruiting

Last update: 2019-10-30, 1398/08/08
Update count: 0
Registration date
2019-10-30, 1398/08/08
Registrant information
Name
parya bakhshpoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4482 3993
Email address
p.bakhshpoori@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Sublingual Buprenorphine and Fentanyl Intravenous Pump for Postoprative Pain Relief After Open Cholecystectomy Surgery.
Public title
Comparison Between Sublingual Buprenorphine and Fentanyl Intravenous Pump for Postoprative Pain Relief After Open Cholecystectomy Surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing open cholecystectomy Patients ASA 1and2 Patients who have no further surgery Age range 20 to 50 years
Exclusion criteria:
History of opium use Nervous drug history Active asthma ASA3 Other concurrent surgery Surgery lasted Complicated surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After patients were allowed to enter the study 80 patients were selected using simple sampling and the selected patients will be divided into two groups by random block design with 4 blocks. In this case all possible modes were considered to accommodate the letters AABB which is 6 modes. These 6cases were embedded in 6 papers and the papers were embedded in a black bag. Then we will make 20 paper bags every time. We draw a piece of paper write down the letters in it and we will add the next letter in the next drawing followed by the previous note we will have 80 letters in the end and at the time of sampling each person will receive a special letter in order of entry into the sample and so the people feel into one group .
Blinding (investigator's opinion)
Double blinded
Blinding description
The first group of 40 patients receiving Sublingual Buprenorphine Tablet and intravenous placebo Pump The second group will consist of 40 patients receiving Sublingual placebo Tablet and intravenous Fentanyl Pump. All Patients will be anesthetized by one-way treatment Protocol. Given that the study is randomly blocked,Buprenorphine and Placebo Buprenorphine and Fntanyl Pump and placebo pump separately and in two packs (Containing one pump and one Tablet) with specific codes B and A (Pack A containing Sublingual Buprenorphine and Placebo Pumps and and Pack B containing Placebo Tablets and Fentanyl Pumps) and The drug injector (Anesthetic Technician) has no information about the contents of the pack Select Pack A or B based on the Patient group. already specified are provided and every morning before the operation the number of Surgeries will be eliminated the same day.Start prescribing housing content envelopes after complete Cholecystectomy And it will be done in recovery. Patients will not be informed about the type of drug they receive.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, Office Complex End of University Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.ARUMS.REC.1398.103

Health conditions studied

1

Description of health condition studied
Comparison between Sublingual Buprenorphine and Fentanyl Intravenous Pump for postoperative pain relief after open Cholecystectomy Surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reduction of pain after open Cholecystectomy
Timepoint
VRS score(Verbal Rating Score) in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated.
Method of measurement
Through the Score Verbal Rating Scale (VRS)

Secondary outcomes

1

Description
Nausea and Vomiting Score after open Cholecystectomy
Timepoint
Nausea and Vomiting in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated.
Method of measurement
By Scoring N&V Score

2

Description
Sedation Score after open Cholecystectomy
Timepoint
Sedation Score(Through the Ramsay relaxation Scale) in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated.
Method of measurement
Through the Ramsay relaxation Scale

Intervention groups

1

Description
In the intervention group, Sublingual Buprenorphine Tablet administered 0.4 mg in 6, 12 and 18 hours recovey and Placebo Pump 50 cc normal saline in recovery and continued for 24 hours, if pain is not controlled, PCA is injected every 15 minutes.
Category
Treatment - Drugs

2

Description
Control group:In the control group, Placebo Tablets were administered at 6,12 and 18 h,50 cc intravenous Fentanyl Pump (40 cc Fentanyl and 10 cc normal saline) embedded and half a cc (20 micrograms) of stat is injected and if the pain is not controlled, PCA is given by the patient.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Training Center of Ardebil
Full name of responsible person
Ahmad Ghazi
Street address
Ardabil Fatemi Hospital , Sarin Station, Imam khomeini Street
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3323 2520
Email
info@arums.ac.ir

2

Recruitment center
Name of recruitment center
Imam khomeini Ardabil Training Center
Full name of responsible person
Ahmad Ghazi
Street address
Imam khomeini Hospital Ardabil, Attai Street, Seaside Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3325 1401
Email
info@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahab Behlouli
Street address
Ardabil University of Medical Sciences, University Street, University square , Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4790
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital , Basij Square
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
009844838649
Email
dr.ghaziahmad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Basij square
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 914 151 5271
Email
dr.ghaziahmad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Basij square
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 914 151 5271
Email
dr.ghaziahmad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to Ethical Problems and Patient safety, The publish of IPD not applicable.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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