Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000908730
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
14/08/2013
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of analgesic efficacy of intrathecal neostigmine added to bupivacaine in Patients undergoing lower limb orthopedic surgery
Scientific title
The effects of intrathecal neostigmine added to bupivacaine on postoperative analgesic requirement in Patients undergoing lower limb orthopedic surgery
Secondary ID [1] 282917 0
nil
Universal Trial Number (UTN)
U1111-1146-4217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain in
Patients undergoing lower limb orthopedic surgery 289731 0
Condition category
Condition code
Anaesthesiology 290059 290059 0 0
Anaesthetics
Surgery 290060 290060 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty patients 18-80 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of two groups of 30 each. The neostigmine group (groupN received bupivacaine 20mg combined with 25 microgram neostigmin ,and The placebo group (group P) received bupivacaine 20 mg combined with 0.5ml distilled water(intrathecally) for each two groups 5 minutes prior to surgery).
Intervention code [1] 287614 0
Prevention
Intervention code [2] 287615 0
Treatment: Drugs
Comparator / control treatment
The placebo group (group P) received bupivacaine 20 mg combined with 0.5ml distilled water
Control group
Placebo

Outcomes
Primary outcome [1] 290111 0
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Timepoint [1] 290111 0
Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Primary outcome [2] 290112 0
Duration of Sensory block will be assessed by a pinprick test
Timepoint [2] 290112 0
The duration of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the reappearance of sensation at the T10 dermatome(sensory block will be assessed by pinprick test every 5minutes following intrathecal injection
Primary outcome [3] 290113 0
Duration of motor block (the time from intrathecal injection to Bromage score 0 will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [3] 290113 0
The time from intrathecal injection to Bromage score 0( motor block will be assessed by the modified Bromage score every 5 minuts following intrathecal injection)
Secondary outcome [1] 303967 0
Systolic and diastolic blood pressure is assessed by nonivasive automatic blood pressure measurement
Timepoint [1] 303967 0
5min before the intrathecal injection,and at 2, 4, 6,8, 10, 15,20 min after the injection
Secondary outcome [2] 304093 0
Adverse effects such as vomiting,pruritus
Timepoint [2] 304093 0
the time from intrathecal injection to 12 hours later

Eligibility
Key inclusion criteria
Patients with American Society of Anesthesiologists(ASA) physical status I and II undergoing elective lower limb surgery
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
significant coexisting disease such as hepato-renal and cardiovascular disease, any contraindication to regional anesthesia such as local infection or bleeding disorders, allergy , long-term opioid use or a history of chronic pain.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by two of the anesthesiologists during preoperative rounding,.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (4.5ml’s) Each syringe will be labeled A ,B according to its contents. . The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the spinal of anesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2013
Actual
1/08/2013
Date of last participant enrolment
Anticipated
23/10/2013
Actual
30/10/2013
Date of last data collection
Anticipated
Actual
30/10/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5251 0
Iran, Islamic Republic Of
State/province [1] 5251 0
Qazvin

Funding & Sponsors
Funding source category [1] 287695 0
Self funded/Unfunded
Name [1] 287695 0
Hamid kayalha
Country [1] 287695 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin Medical Science University
Address
Shahid bahonar,Ave3419759811 Qazvin ,
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286428 0
Hospital
Name [1] 286428 0
Rajaei Hospital
Address [1] 286428 0
Padegan street,Qazvin,
postal code:3413996134
Country [1] 286428 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289655 0
Qazvin Medical University Science
Ethics committee address [1] 289655 0
shahid bahonar,Ave3419759811 Qazvin ,
Ethics committee country [1] 289655 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 289655 0
20/05/2013
Approval date [1] 289655 0
24/07/2013
Ethics approval number [1] 289655 0
2820/7664

Summary
Brief summary
Objective : To evaluate the analgesic efficacy of neostigmine as an additive to intrathecal bupivacaine.
Methods: Following Ethics Committee approval and informed patients consent, Sixty patients 18-80 yr old ASA physical status I or II, scheduled for lower limb surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of two groups of 30 each. The neostigmine group (group N) received bupivacaine 20 mg combined with 25microgram 0.5ml neostigmine and the placebo group (group P) received bupivacaine 20 mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement , postoperative analgesic requirements duration of sensory and motor blockade, hemodynamics variables, and Adverse events such as hypoxia (oxygen (SpO2)<90], bradycardia hypotension, postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, pethidine 25 mg intravenously , was to be given for post-operative pain relief as needed .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41806 0
Dr Hamid Kayalha
Address 41806 0
Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar postal code:34188 99578
Country 41806 0
Iran, Islamic Republic Of
Phone 41806 0
+98 -912-182-5385
Fax 41806 0
Email 41806 0
[email protected]
Contact person for public queries
Name 41807 0
Dr Zinat Musavi
Address 41807 0
,Resident ofAnesthesiology,Qazvin Medical Science University,shahid bahonar,Ave3419759811 Qazvin ,Iran
Country 41807 0
Iran, Islamic Republic Of
Phone 41807 0
+98- 912-3826170
Fax 41807 0
Email 41807 0
[email protected]
Contact person for scientific queries
Name 41808 0
Dr Marzieh Beigom Khezri
Address 41808 0
, Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar postal code:34188 99578
Country 41808 0
Iran, Islamic Republic Of
Phone 41808 0
+98-912-3811009
Fax 41808 0
+98-281-2236378
Email 41808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Middle East J Anaesthesiol. 2015 Jun;23(2):199-204... [More Details] 364687-(Uploaded-15-11-2018-03-32-33)-Journal results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
46Study results articleYes Middle East J Anaesthesiol. 2015 Jun;23(2):199-204... [More Details] 364687-(Uploaded-15-11-2018-03-32-33)-Journal results publication.pdf
2818Plain language summaryNo Patients receiving neostigmine had a significantl... [More Details]

Documents added automatically
No additional documents have been identified.