The effect of Continous TAP block on post operative morphine sulphate consumption after elective laparoscopic cholecystectomy in patients of Shariati Hospital
The aim of this study is to determine the effect of continuous TAP Block on opioid intake after surgery in patients undergoing laparoscopic cholecystectomy. Inclusion criteria consist of age 25 to 60 years; class 1 and 2 ASA that are candidate for laparoscopic cholecystectomy; no history of drug addiction; no history of allergy to study medications; no mental disorders; no coagulopathy; no hepatomegaly nor splenomegaly; no chronic pain disorder. Exclusion criteria consist of the patient determent; surgery time more than two hours; any intraoperative complication and failure of blocks. The patients were randomly divided into two groups of 17 people. In the intervention group continuous TAP block with catheter insertion and PCA morphine is considered. After surgery in the recovery room and 2, 6, 12 and 24 hours later in patients with NRS> 3, 16cc bupivacaine 0.25% prescribed. PCA morphine for pain control is considered in the control group. Outcomes included total amount of opioid consumption, pain intensity, duration of hospitalization, complications, time of the first injection of opioid with PCA and the first injection of drug through the catheter that are evaluated and analyzed.
General information
Acronym
TAP Block: transverse abdominis plane block
IRCT registration information
IRCT registration number:IRCT2016110630735N1
Registration date:2016-12-23, 1395/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Elham Naseh
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 84901
Email address
enaseh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Continous TAP block on post operative morphine sulphate consumption after elective laparoscopic cholecystectomy in patients of Shariati Hospital
Public title
The effect of Abdominal nerves block on post operative morphine consumption after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consist of age 25 to 60 years; class 1 and 2 ASA that are candidate for laparoscopic cholecystectomy; no history of drug addiction; no history of allergy to study medications; no mental disorders; no coagulopathy; no hepatomegaly nor splenomegaly; no chronic pain disorder.
Exclusion criteria: the patient determent; surgery time more than two hours; any intraoperative complication and failure of blocks.
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic cmmittee,faculty of medicine of Tehran University of mdical science
Street address
Tehran universiy of medical science, faculty of medicine, Poorsina street,Keshavarz avenue
City
Tehran
Postal code
1411713135
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.TUMS.REC.1394.634
Health conditions studied
1
Description of health condition studied
Elective laparoscopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
Immidiatly after surgery in the recovery room and 2, 6, 12, 24 hours after surgery
Method of measurement
NRS (Numerical Rating Scale)
2
Description
Post operative morphin sulphate consumption
Timepoint
0, 2, 6, 12, 24 hours after surgery
Method of measurement
milligram
Secondary outcomes
1
Description
Post operative side effects
Timepoint
0, 2, 6, 12, 24 hours after surgery
Method of measurement
Patient Medical Records
2
Description
Duration of hospital stay
Timepoint
Discharge time
Method of measurement
Patient Medical Records
Intervention groups
1
Description
intervention Groups: in the intervention group TAP block with 20cc bupivacaine 0.5% and catheterization is performed in the same place. Then 10 mL of bupivacaine 0.25% is injected through the catheter if NRS>3 after 2, 6, 12, 18 hours after surgery. The PCA with morphine 1cc = 1mg stay there all the time.
Category
Treatment - Drugs
2
Description
Control group: after surgery just under PCA with morphine sulphate 1cc=1mg and record NRS score at 2, 6, 12, 24 hours after surgery and total morphin consumption
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh-professor of anestheiology
Street address
Shariati hospital, North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller of research, Faculty of Medicine, Tehran University of Medical Siences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of Medicine,Tehran University of Medical sciences, Poorsina street, Keshavarz avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller of research, Faculty of Medicine, Tehran University of Medical Siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Naseh
Position
MD, Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 84901
Fax
+98 21 8863 3039
Email
elhamnaseh63@gmailcom
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Shariati hospital, North Kargar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 84901
Fax
+98 21 8863 3039
Email
ali.movafegh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Naseh
Position
MD, Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 84901
Fax
+98 21 8863 3039
Email
elhamnaseh63@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)