Objective: Clinical trial of evaluation the effect of intrathecal midazolam in combination with fentanyl in strengthening analgesic effect in the lower limb surgery. Design of the study: randomization using random permuted blocks, convenience sampling, double-blind, single-center, phase II trial. Study population: all patients of lower limb surgery with ASA PS I and II. Main inclusion criteria: age limitation 20-60 years; candidates of lower limb surgery with ASA PS I and II. Main exclusion criteria: contraindications to intrathecal analgesia; history of chronic pains; addiction; NSAID usage 12 hours prior to surgery. Sample size: 90. Interventions: First group: intravenous infusion of 3 cc of 0.5% marcaine plus 0.7 cc 0.09% normal saline; second group: intravenous infusion of 3 milligrams of 0.5% marcaine plus 25 micrograms phentanyl plus 0.2 cc 0.09% normal saline; third group: intravenous infusion of 3 cc of 0.5% marcaine in combination with 25 micrograms phentanyl and 1 milligrams midazolam. Intervention time: before the operation. Outcomes: duration of sensory nerve block; duration of motor block.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030732923N1
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Sima Davarpanah
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
dr.davarpanah@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intrathecal midazolam in strengthening the analgesic effect of intrathecal fentanyl in patients undergoing lower limb surgery
Public title
Evaluation the effect of intrathecal midazolam in combination with fentanyl in strengthening analgesic effect in the lower limb surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: age limitation 20-60 years; candidates of lower limb surgery with ASA PS I and II. Main exclusion criteria: contraindications to intrathecal analgesia; history of chronic pains; addiction; NSAID usage 12 hours prior to surgery.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2016-09-21, 1395/06/31
Ethics committee reference number
IR.ZAUMS.REC.1395.31
Health conditions studied
1
Description of health condition studied
Lower limb surgery
ICD-10 code
Y83
ICD-10 code description
Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Duration of sensory nerve block
Timepoint
Two houres, four houres, eight houres, 12 houres and 24 houres after surgery
Method of measurement
Sensory evaluation of patients with needle based on the time in minutes
2
Description
duration of motor block
Timepoint
Two houres, four houres, eight houres, 12 houres and 24 houres after surgery
Method of measurement
Evaluation of lower extremity mobility through mbs2 based on the time in minutes
Secondary outcomes
empty
Intervention groups
1
Description
First group: intravenous infusion of 3 cc of 0.5% marcaine plus 0.7 cc of 0.09% normal saline
Category
Treatment - Drugs
2
Description
Second group: intravenous infusion of 3 cc of 0.5% marcaine plus 25 micrograms phentanyl plus 0.2 cc 0.09% normal saline
Category
Treatment - Drugs
3
Description
Third group: intravenous infusion of 3 cc of 0.5% marcaine in combination with 25 micrograms phentanyl and 1 milligrams of midazolam