1. Home
  2. Approved trials
  3. » فارسی

Evaluation of adding clonidine to bupivacaine in supraclavicular block with catheter insertion for upper extremity surgery

Protocol summary

Summary
Goals: Evaluation of sensory and motor blockade and side effects of adding clonidine 75 mcg to bupivacaine in supraclavicular brachial plexus blockade with catheter insertion for upper extremity procedures. Methods: In this randomized, double-blind, controlled trial, sixty patients, aged 20–60 years, with ASA (American Society of Anesthesiologists) status classification I or II who were candidate for upper extremity orthopedic surgery under supraclavicular brachial plexus blockade were allocated in two groups (30 in each group). The supraclavicular blockade was performed by peripheral nerve stimulator and anesthetic solutions were injected after desirable muscular responses. Control group (B) received 0.5% bupivacaine 25 ml, and study group (BC) received 0.5% bupivacaine 25 ml contained 75 mcg clonidine. After that, supraclavicular catheter was indwelt for additional injections. For additional intraoperative analgesia, 5 ml of bupivacaine 0.5% was administrated through catheter, along with IV sufentanil and midazolam. Onset of complete sensory and motor blockade, intraoperative drug administraded (bupivacaine, sufentanil and midazolam) complications, duration of postoperative analgesia and motor blockade, time to first postoperative analgesic request, and demographic data were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138805312366N1
Registration date: 2010-02-20, 1388/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
imani.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences (IUMS)
Expected recruitment start date
2003-12-22, 1382/10/01
Expected recruitment end date
2004-12-21, 1383/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding clonidine to bupivacaine in supraclavicular block with catheter insertion for upper extremity surgery
Public title
Evaluation of adding clonidine to local anesthetic in regional anesthesia for upper extremity surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20–60 years (ASA physical status I or II) of both sex, who were candidate for upper extremity (hand, forearm, elbow or arm) surgery, referred to Rasool-Akram hospital. Exclusion criteria: severe uncontrolled underlying diseases (coagulopathy, seizure, cardiac, ...), history of cigarette, opioid, or alcohol abuser, allergy to local anesthetic or clonidine , patient refusal
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Iran University of Medical Sciences
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Postal code
14496
Approval date
2009-05-04, 1388/02/14
Ethics committee reference number
161

Health conditions studied

1

Description of health condition studied
Fracture of upper limb
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb

2

Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
sensory and motor blockade in upper extremity
Timepoint
from start of injection to one hour after surgry
Method of measurement
physical exam of sensation and movement in the upper limb

Secondary outcomes

1

Description
complications
Timepoint
from start of injection to one hour after surgry
Method of measurement
patient evaluation and observation

Intervention groups

1

Description
Intervention group: adding clonidine 75 mcg to bupivacaine 0.5% in supraclavicular blockade
Category
Treatment - Drugs

2

Description
Control group: administration of 25 ml bupivacaine 0.5% for supraclavicular blockade
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-Akram Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Full name of responsible person
Akbar Sharafi M.D. Vice chancellor for research
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences (IUMS)
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
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital,
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Rasool-Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman/ Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...