Objectives: We conducted this study to assess whether coadministration of ketamine would enhance or prolong local analgesic effect of lidocaine in supraclavicular brachial plexus block for patients undergoing elective upper extremity surgery.
Patients with age between 15 and 60 years ; American Society of Anesthesiologists (ASA) classes I - II included and patient with preexisting neuropathy ; hepatic or renal impairment ; allergy to drugs used in this study ; infection at the injection site ; prior surgery in the supraclavicular, infraclavicular or axillary regions ; alcohol or drug abuse ; ; refusal of the patient excluded.
Methods: Sixty adult patients undergoing elective surgery of the elbow, forearm, wrist, or hand were randomly allocated in two groups of thirty patients each. Group 1 (ketamine group) received 3 mg/kg lidocaine plus 2 mg/kg ketamine, Group 2 (control group) received 3 mg/kg lidocaine and saline.This randomized, double blinded clinical trial was conducted between November 2012 and November 2013 in the two teaching hospitals (Ayatollah Kashani and Alzahara Hospital) of Isfahan University of Medical Sciences. Outcome measures included onset times and duration of sensory and motor block, pain and satisfaction scores, time to first request for analgesia, total dose of postoperative opioid, and adverse events.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091414661N1
Registration date:2014-02-20, 1392/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Mohammadreza Lashgarinia
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1776 0300
Email address
dr.lashgarinia@irimc.org
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2012-11-01, 1391/08/11
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ketamine as Adjuvant in Ultrasound Guided Supraclavicular Brachial Plexus Block
Public title
Ketamine and post operative pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria : Patients with age between 15 and 60 years ; American Society of Anesthesiologists (ASA) classes I - II ; and body mass index (BMI) between 20 and 35 kg/m2.
Exclusion criteria : preexisting neuropathy, coagulopathy ; hepatic or renal impairment ; severe pulmonary disease ; allergy to drugs used in this study ; infection at the injection site ; pregnancy or lactation ; prior surgery in the supraclavicular, infraclavicular or axillary regions ; alcohol or drug abuse ; duration of operation more than 120 min or less than 30 min ; refusal of the patient.
Age
From 15 years old to 60 years old
Gender
Both
Phase
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Isfahan.Iran
City
Isfahan
Postal code
Approval date
2012-07-10, 1391/04/20
Ethics committee reference number
291195
Health conditions studied
1
Description of health condition studied
regional anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Post operative pain
Timepoint
the first 24hours post operatively
Method of measurement
VAS
Secondary outcomes
1
Description
onset times and duration of sensory and motor block
Timepoint
intra operative
Method of measurement
by chornometer
Intervention groups
1
Description
Group 1(ketamine group) received 3 mg/kg lidocaine and 2 mg/kg ketamine.
Category
Treatment - Other
2
Description
Group 2 (control group) received 3 mg/kg lidocaine and 0.9% sodium chloride in the same volume of ketamine 2% if was used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Kashani hospitals
Full name of responsible person
Dr.Azim Honarmand
Street address
Isfahan University of Medical Science
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Peyman Adibi
Street address
Isfahan University of Medical Science,VCR office
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
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
Isfahan University of Medical Science
Full name of responsible person
Dr.Azim Honarmand
Position
associated professor
Other areas of specialty/work
Street address
Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
honarmand@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Azim Honarmand
Position
associated professor
Other areas of specialty/work
Street address
Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
honarmand@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Azim Honarmand
Position
associated professor
Other areas of specialty/work
Street address
Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
honarmand@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)