Effect of Addition of Clonidine to Bupivacaine in Spinal Anesthesia on Analgesia and Hemodynamic after Cruciate Ligament Repair: A Randomized Double Blinded Clinical Trial
This study sought to assess the effect of addition of clonidine to bupivacaine in spinal anesthesia on analgesia after cruciate ligament repair. Fifty patients undergoing ACL reconstruction surgery divided into two groups. An anesthesiologist prepared drugs and another anesthesiologist injected drugs for patients. The first group received 0.5% bupivacaine with a total dose of 15 mg plus 0.5 ml saline solution and group 2 received 15 mg 0.5% bupivacaine plus 75 μg clonidine with a total volume of 0.5 ml intrathecally. Patients received 1-2 mg midazolam for sedation prior to surgery and 5ml/kg saline solution during 15-20 min. During the operation, oxygen supplementation was carried out at a rate of 6 L/min. Spinal anesthesia was induced using a #26 needle inserted through L3-L4 or L4-L5 with midline method. During the operation, 1 mg midazolam was administered if sedation was needed. Patient’s blood pressure, Ramsay score, VAS, SpO2 and pulse rate were measured and recorded every 15 min. Time to request analgesics and the VAS score at the time of request were also recorded. These data were compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062117413N5
Registration date:2014-06-29, 1393/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences Deputy of Research
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Addition of Clonidine to Bupivacaine in Spinal Anesthesia on Analgesia and Hemodynamic after Cruciate Ligament Repair: A Randomized Double Blinded Clinical Trial
Public title
Effect of Addition of Clonidine to Bupivacaine in Spinal Anesthesia on Analgesia after Cruciate Ligament Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate ACL reconstruction surgery under spinal anesthesia at Baqiyatallah Hospital; Age over 18. Exclusion criteria: history of chronic pain; multiple trauma; long-term consumption of opioids and analgesics; history of alcohol consumption; absolute or partial contraindication of spinal injections; allergy to clonidine and bupivacaine.
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
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
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
30-22
Health conditions studied
1
Description of health condition studied
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
ICD-10 code
S83.5
ICD-10 code description
injury of cruciate ligament of knee
Primary outcomes
1
Description
Two Sensory Dermatome Regression Time
Timepoint
After operation
Method of measurement
Minute
2
Description
Motor Regression time
Timepoint
After operation
Method of measurement
Minute
3
Description
Post operative pain severity
Timepoint
at the time of needing analgesia
Method of measurement
visual analogue score (0-10)
4
Description
Time of needing analgesia
Timepoint
After operation
Method of measurement
Minute
Secondary outcomes
1
Description
voiding time
Timepoint
After operation
Method of measurement
Minute
2
Description
Blood pressure
Timepoint
After operation
Method of measurement
mmHg
Intervention groups
1
Description
Second group received 15 mg 0.5% bupivacaine plus 75 μg clonidine with a total volume of 0.5 ml intrathecally.
Category
Treatment - Drugs
2
Description
The first group received 0.5% bupivacaine with a total dose of 15 mg plus 0.5 ml saline solution intrathecally.