With the aim of evaluating prophylactic effect of oral gabapentin on intrathecal opioid-induced pruritus and after obtaining approval from Emam Khomeini research board and ethics committee of Urmia University Of Medical Sciences, 80 male and female patients with class I-II American Society of Anesthesiologist (ASA) aged 20-50 scheduled for elective lower limb orthopedic surgery under spinal anesthesia will be enrolled in the study. Patients with any contraindication of spinal anesthesia; any pruritus before surgery; known history of allergy to gabapentin; morbid obesity; history of skin disease and any systemic disorder accompanying pruritus will be excluded from the study. The patients with be allocated to study and placebo groups using random allocation software. The study and placebo group patients will receive 600 milligram oral gabapentin and placebo two hours before induction of anesthesia respectively. In the operating room, IV cannula will be inserted and standard monitoring including blood pressure, EKG and pulse oximetry will be attached to all the patients. Then 5 cc/Kg Ringer solution will be infused. Spinal anesthesia will be induced using 12 milligrams 0.5 % hyperbaric bupivacaine and 30 microgram fentanyl in a sterile manner and the time of injection will be recorded. One hour after intrathecal injection, the patients will be asked about the feeling of pruritus, its locations and severity, and nausea and vomiting. As occurrence, nausea and vomiting will be managed with 8 mg dexamethasone and 10 mg metoclopramide intravenously. Again, the patients will be evaluated at hours 6, 12 and 24 following intrathecal injection and will be evaluated about aforementioned complaints and will be managed accordingly as occurrence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017033025600N4
Registration date:2017-05-21, 1396/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-21, 1396/02/31
Registrant information
Name
Shahram Shokohi
Name of organization / entity
Urmia University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
shokohi.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University Of Medical Sciences
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic effect of gabapentin on intrathecal fentanyl-induced pruritus in orthopedic patients
Public title
The effect of gabapentin on intrathecal opioid-induced pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male and female patients with class I-II American Society of Anesthesiologist (ASA) aged 20-50 scheduled for elective lower limb orthopedic surgery under spinal anesthesia
Exclusion criteria: any contraindication of spinal anesthesia; any pruritus before surgery; known history of allergy to gabapentin; morbid obesity; history of skin disease and any systemic disorder accompanying pruritus
Age
From 20 years old to 50 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In an attempt to achieve a higher standard of scientific rigor, the study has planned as a double-blind experiment. By using this, biases carried by and experiment’s subject and researcher will be eliminated. Regarding the probability of conscious and unconscious biases, the study is planned as a double-blind placebo-controlled clinical trial research.In these double-blind experiments, neither the participants nor the researchers know which participants belong to the control group, nor the test group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Urmia University Of Medical Sciences
Street address
Urgence street,Resaalat boulevard
City
Urmia
Postal code
Approval date
2016-10-26, 1395/08/05
Ethics committee reference number
IR.umsu.rec.1395.302
Health conditions studied
1
Description of health condition studied
Intrathecal opioid-induced pruritus
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics
Primary outcomes
1
Description
Intrathecal fentanyl-induced pruritus
Timepoint
At hours 1, 6, 12 and 24 after intratethcal fentanly injection
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
600 milligram oral gabapentin, 2 hours before intrathecal fentanyl injection
Category
Treatment - Drugs
2
Description
Oral placebo 2 hours before intrathecal fentanyl injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Emam Khomeini teaching hospital
Full name of responsible person
Dr. Shahram Shokohi
Street address
Department of anesthesiology, Ershad street, Modarres boulevard
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of resrearch, Urmia University Of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urgence avenue, Jahad street, Resalat boulevard
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of resrearch, Urmia University Of Medical Sciences
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
Urmia University Of Medical Sciences
Full name of responsible person
Dr. Shahram Shokohi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of anesthesiology,Emam Khomeini teaching hospital, Ershad avenue, Modarres boulevard