The effect of 3-in-1 block with bupivacaine 0.25% versus bupivacaine 0.25% plus 8 milligram dexamethaasone in acute pain control of patients undergone hip nailing surgery
The purpose of this randomized, double blinded clinical trial is to evaluate the effect of 3-in-1 block with bupivacaine 0.25% versus bupivacaine 0.25% plus 8 milligrams of dexamethasone in acute pain control of the patients undergoing elective hip nailing surgery. So we will randomly divide 44 ASA class I-III patients into two groups and depending on the group the patient will receive 3-in-1 block with bupivacaine 0.25% or bupivacaine 0.25% plus 8 milligrams of dexamethasone at the end of the surgery and we will measure post operative pain score with visual analog scale in certain periods of time during 24 hours post operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201158728N1
Registration date:2012-02-25, 1390/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-25, 1390/12/06
Registrant information
Name
Afshin Amini
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5280
Email address
khalediar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 3-in-1 block with bupivacaine 0.25% versus bupivacaine 0.25% plus 8 milligram dexamethaasone in acute pain control of patients undergone hip nailing surgery
Public title
The effect of femoral block with bupivacaine in pain control of patients undergone hip nailing surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 50-80; ASA Class: I-III; Elective surgery.
Exclusion criteria: Patients <50 or >80 years old; Weight >110 or <50; History of substance abuse and addiction; History of allergy to local anesthetics; Peripheral neuropathy; any neurologic deficit; Abnormal coagulation profile; Mental retardation; dementia; Inability to undrestand the pain score system.
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street
Presense of sense in the territory of 2 blocked nerves
2
Description
Nausea and/or vomiting
Timepoint
Hours of 0, 1/2 and 1
Method of measurement
Physician observation or patient complaint
3
Description
Arrhythmia and/or hypotension
Timepoint
Hours of 0, 1/2 and 1
Method of measurement
Monitoring the patient
4
Description
Hematoma
Timepoint
Hours of 0, 1/2, 1, 6, 12, 24
Method of measurement
Physician observation
Intervention groups
1
Description
For the control group: After approval of ethics committee, written and verbal consent will be obtained from the patients. All patients will be instructed on the 10 point visual analog scale. Anesthetic induction will be achieved with 0.03 mg/kg midazolam, 2 µ/kg fentanyl, 4-6 mg/kg thiopental and 0.5-0.6 mg/kg atracurium. For maintenance we will administer 1- 1.5 % Isoflurane and 50% N2O-50% O2 mixture. Remifentanil will be added (0.1-0.2 µg/kg/min) when there is an increase more than 30% from the baseline mean blood pressure or pulse during the surgery. At the end of surgery reversal will be administered for reversing muscle relaxation and before the patient is awake, with sufficient disinfection of the area, femoral 3-in-1 block will be performed by a physician blinded to study. The femoral nerve will be localized with the help of the peripheral nerve stimulator B|Braun. The presence of continuing contractions in the quadriceps femoris muscle at a value of 0.5 mA is acceptable. While the needle is held in this position, 40 ml of 0.25% bupivacaine solution will be injected following a negative aspiration. The injection will be carried out within a period of two minutes with distal pressure application to increase the spread of the local anesthetic within the psoas sheath. After that the patient will be transferred to recovery with endotracheal tube and will be extubated in recovery room after awakening. The patients will be monitored for blood pressure, heart rate and O2 saturation for 1 hour and also they will be evaluated for any side effects such as nausea, vomiting, arrhythmia, decreased level of consciousness, hypotension and hematoma in the site of injection. Presence of sensory block in the femoral, obturator and lateral cutaneous nerve dermatomes will be tested with the pin-prick and if there is sense on the territory of 2 nerves the patient will be omitted from the study due to failure of block and another patient will be replaced. Pain score will be measured by visual analog scale (VAS) at the times of 0, 1/2, 1, 6, 12, and 24 (One hour after block is time 0) by a physician blinded to group of the patient. A VAS value of 3 will be accepted as an adequate level of analgesia. During the study if the patient develops VAS ≥ 4, 2 milligrams of IV morphine will be administered slowly every half hour if necessary till it reaches below 4. Finally the patients will be asked to evaluate the general satisfaction of the pain treatment at the end of 24 hours (3=perfect, 2=good, 1=moderate and 0=bad).
Category
Treatment - Drugs
2
Description
For the intervention group: After approval of ethics committee, written and verbal consent will be obtained from the patients. All patients will be instructed on the 10 point visual analog scale. Anesthetic induction will be achieved with 0.03 mg/kg midazolam, 2 µ/kg fentanyl, 4-6 mg/kg thiopental and 0.5-0.6 mg/kg atracurium. For maintenance we will administer 1- 1.5 % Isoflurane and 50% N2O-50% O2 mixture. Remifentanil will be added (0.1-0.2 µg/kg/min) when there is an increase more than 30% from the baseline mean blood pressure or pulse during the surgery. At the end of surgery reversal will be administered for reversing muscle relaxation and before the patient is awake, with sufficient disinfection of the area, femoral 3-in-1 block will be performed by a physician blinded to study. The femoral nerve will be localized with the help of the peripheral nerve stimulator B|Braun. The presence of continuing contractions in the quadriceps femoris muscle at a value of 0.5 mA is acceptable. While the needle is held in this position, 40 ml of 0.25% bupivacaine plus 8 milligrams of dexamethasone solution will be injected following a negative aspiration. The injection will be carried out within a period of two minutes with distal pressure application to increase the spread of the local anesthetic within the psoas sheath. After that the patient will be transferred to recovery with endotracheal tube and will be extubated in recovery room after awakening. The patients will be monitored for blood pressure, heart rate and O2 saturation for 1 hour and also they will be evaluated for any side effects such as nausea, vomiting, arrhythmia, decreased level of consciousness, hypotension and hematoma in the site of injection. Presence of sensory block in the femoral, obturator and lateral cutaneous nerve dermatomes will be tested with the pin-prick and if there is sense on the territory of 2 nerves the patient will be omitted from the study due to failure of block and another patient will be replaced. Pain score will be measured by visual analog scale (VAS) at the times of 0, 1/2, 1, 6, 12, and 24 (One hour after block is time 0) by a physician blinded to group of the patient. A VAS value of 3 will be accepted as an adequate level of analgesia. During the study if the patient develops VAS ≥ 4, 2 milligrams of IV morphine will be administered slowly every half hour if necessary till it reaches below 4. Finally the patients will be asked to evaluate the general satisfaction of the pain treatment at the end of 24 hours (3=perfect, 2=good, 1=moderate and 0=bad).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Amin Reza Khaledi - Resident of anesthesiology and critical care
Street address
Chamran Boulevard
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Amini M.D
Street address
Central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amin Reza Khaledi M.D
Position
Resident of anesthesiology and critical care
Other areas of specialty/work
Street address
Department of anesthesiology, Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 1623 5280
Fax
Email
khalediar@sums.ac.ir;khaledi_amin@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Amini M.D
Position
Assistant Professor of anesthesiology
Other areas of specialty/work
Street address
Asateed-e Daneshghah Building, East Ghoddoosi boulevard
City
Shiraz
Postal code
Phone
+98 71 1233 1549
Fax
Email
aamini@sums.ac.ir;afshinaminie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin Reza Khaledi M.D
Position
Resident of anesthesiology and critical care
Other areas of specialty/work
Street address
Department of anesthesiology, Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 1623 5280
Fax
Email
khalediar@sums.ac.ir;khaledi_amin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)