The effect of preoperative ultrasound-guided femoral block on post-operative pain management in hip replacement surgery compare with postoperative intra venous morphine administration
The effect of preoperative ultrasound-guided femoral block on post-operative pain management in hip replacement surgery compare with postoperative intra venous morphine administration
Design
Randomized control trial with parallel group phase 3 on 60 patients, randomized by block randomization from randomization .com site
Settings and conduct
This study will be done in Emam Reza hospital of Mashhad and patients with hip fracture who needs replacement therapy divided in two groups by randomization. In case group the patients undergo a femoral block and both groups undergo general anesthesia for replacement surgery; pain will be evaluate by NRS scale 1 hour after entering to the recovery and then every 4 hours for the next 12 hours and the day after the surgery. In the case of NRS more than 3, 0.5 mg /kg Morphine will be prescribed intravenously for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with hip fracture and need to hip replacement therapy; age: 40 to 80 years old.
Exclusion criteria: any kind of neurologic disease; history of consuming of opioids or antipsychotic drugs and hypersensitivity to anesthesia or local anesthetic drugs.
Intervention groups
Patients in intervention group undergo a femoral block. After preparing of the groin region femoral nerve will be find by ultrasound linear probe and will be approached by nerve stimulator needle and after observing quadriceps contracture by 0.5 milliampere stimulation; 5 ml 2 percent Lidocaine with 5 ml 0.5percent Bupivacaine and 50 microgram fentanyl will be injected. No intervention are supposed to do for control group. Both groups undergoes general anesthesia for replacement surgery.
Main outcome variables
Pain intensity with NRS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150826023772N2
Registration date:2021-02-13, 1399/11/25
Registration timing:prospective
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
mehrdad mokaram dori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3878
Email address
mokarramdm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative ultrasound-guided femoral block on post-operative pain management in hip replacement surgery compare with postoperative intra venous morphine administration
Public title
Femoral nerve block for post operative pain control of hip replacement therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 40 to 80 years old with hip fracture
Candidate for hip replacement surgery
ASA class 1 or 2
Written consent has received
Exclusion criteria:
History of consuming of opioids or antipsychotic drugs
Any kind of neurologic disease
History of hypersensitivity to anesthesia or local anesthetic drugs
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Envelop method in which one of the research group print and prepare envelops by evolving randomized numbers from the Randomized.com site. The envelops are sealed and invisible. After explaining of the study propose and receive the written consent the patient choose one envelop and enter to one the two groups of trial or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer will not aware of the intervention group and the data will be delivered to analyzer in just two groups of A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Pardis University, Mashhad University of Medical Scienceَs, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-01-23, 1399/11/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.610
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
Y83.4
ICD-10 code description
Other reconstructive surgery as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Pain score in questioner
Timepoint
1 hour after entering to the recovery and then every 4 hours for next 12 hours and the day after operation
Method of measurement
Pain score with numerical rating scale (NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Under ultrasound guidance needling will be done with a nerve stimulator needle and after observation of quadriceps muscle contracture by 0.5 ampere, Femoral nerve will be blocked by injection of a solution contains 5 ml 2 percent Lidocaine and 5 ml 0.5 percent bupivacaine with 50 microgram fentanyl.
Category
Treatment - Drugs
2
Description
Control group: In control group and in the case of the pain exacerbation more than 3 in NRS scale ; 0.05 mg per Kg Intravenous Morphine will be prescribed every 6 hours.