]>
IRCT201201158728N1 IRCT 2012-02-25 Shiraz University of Medical Sciences The effect of femoral block with bupivacaine in pain control of patients undergone hip nailing surgery 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 2012-01-21 anticipated 44 Complete https://irct.ir/trial/9219 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Intertrochanteric fracture. Intervention 1: 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). Intervention 2: 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).
public Amin Reza Khaledi M.D
Department of anesthesiology, Faghihi Hospital
Shiraz Iran (Islamic Republic of) +98 71 1623 5280 khalediar@sums.ac.ir;khaledi_amin@yahoo.com Shiraz University of Medical Sciences scientific Afshin Amini M.D
Asateed-e Daneshghah Building, East Ghoddoosi boulevard
Shiraz Iran (Islamic Republic of) +98 71 1233 1549 aamini@sums.ac.ir;afshinaminie@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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. 50 years 80 years Both S72.1 Intertrochanteric fracture , Trochanteric fracture Treatment - Drugs Treatment - Drugs 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). 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). Pain. Timepoint: Hours of 0, 1/2 , 1, 6, 12, 24. Method of measurement: Visual analog scale. Failure of block. Timepoint: Hours of 0 and 1/2. Method of measurement: Presense of sense in the territory of 2 blocked nerves. Nausea and/or vomiting. Timepoint: Hours of 0, 1/2 and 1. Method of measurement: Physician observation or patient complaint. Arrhythmia and/or hypotension. Timepoint: Hours of 0, 1/2 and 1. Method of measurement: Monitoring the patient. Hematoma. Timepoint: Hours of 0, 1/2, 1, 6, 12, 24. Method of measurement: Physician observation. Shiraz University of Medical Sciences Approved 2012-01-05 Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Zand street Shiraz Iran (Islamic Republic of)