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Trial registered on ANZCTR


Registration number
ACTRN12615000508572
Ethics application status
Approved
Date submitted
19/01/2015
Date registered
20/05/2015
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of adding magnesium sulphate to fentanyl and bupivacaine for spinal anaesthesia in patients undergoing lower limb orthopedic surgery
Scientific title
The effect of adding magnesium sulphate to fentanyl and bupivacaine on the duration of spinal anaesthesia in patients undergoing lower limb orthopedic surgery
Secondary ID [1] 285994 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
duration of spinal anaesthesia in lower limb orthopedic surgery 293949 0
Condition category
Condition code
Anaesthesiology 294249 294249 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly allocated to one of three groups (33 patients in each group) using closed envelop method.
Group F (n=33): patients will receive a premixed solution of 3 ml (0.5%) hyperbaric bupivacaine, 0.5 mL (25 microgram fentanyl) with 0.5 ml preservative free saline by spinal injection.
Group M(n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mLof 10% MgSO4 with 0.5 ml preservative free saline by spinal injection.
Group M + F (n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mL (25 microgram) fentanyl with 0.5 mL of 10% MgSO4 by spinal injection.
Lumbar puncture for the patients in the sitting position will be performed under complete aseptic conditions at L3-4 or L4-5 interspaces with a 25- gauge spinal needle using a midline approach. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, the premixed anesthetic solution will be injected. Immediately after intrathecal injection of the local anaesthetic, patients will be turned into the supine position. Oxygen 3 L/min was applied to all patients via nasal prongs. Surgery will be permitted after ensuring T8 sensory block to pin-prick.
Intervention code [1] 290972 0
Treatment: Drugs
Intervention code [2] 290973 0
Prevention
Comparator / control treatment
fentanyl group (f) group
Control group
Active

Outcomes
Primary outcome [1] 294046 0
duration of spinal anesthesia
Timepoint [1] 294046 0
Duration of spinal anesthesia will be assessed as the period from spinal injection to the time of administration of first rescue analgesic for pain postoperatively.
Secondary outcome [1] 312409 0
onset and time of sensory block .
Timepoint [1] 312409 0
sensory block will be assessed by pin-prick exam , time to sensory block (time from intrathecal injection of drugs to reach T10 sensory level), the highest dermatomal level , the time to two segments regression from the previous highest dermatomal level, and the duration of sensory block (time from the onset of sensory block till regression to S1).
Sensory block will be evaluated at the same time interval as the hemodynamic variables every 2min, 4min , 6min ,8min , 10min , 20min , 40min , 60min , 80min , 100min , 120min 140min , 160min , 180min and 200mins .
Secondary outcome [2] 312410 0
The time and amount of post-operative analgesic requirement
Timepoint [2] 312410 0
At the end of surgery, patients will be transferred to the PACU. The level of pain based on visual analog scale (VAS) (where 0= no pain and 100= worst pain) will be assessed immediately after surgery, 1 h, 2 h, 4h, 6 h, 8h, 12h, 16h, 20h and 24 h after surgery.Whenever VAS >30, postoperative analgesia will be provided with i.v. ketorolac 30 mg/6 h. After 30 min of ketorolac injection, i.v. fentanyl 0.5 micro gram/kg will be available if VAS still >30. Fentanyl injection can be repeated, provided that 4 h at least should be passed since the last dose
Secondary outcome [3] 312411 0
The incidence of side effects.
Timepoint [3] 312411 0
Nausea, vomiting,bradycardia, low blood pressure, shivering, sedation, and itching and urine retention will be reported every 1 hour up to 24 hours post oprative. Return of bladder function (passing urine) or bowel movements (passing flatus/stools) in first 24 hours will be recorded as present/ absent and the time of their return will be also recorded.
Secondary outcome [4] 314688 0
onset and duration of motor block.
Timepoint [4] 314688 0
Motor blockade of the lower extremity muscles will be assessed using Bromage Score: (0= no motor block, ability to raise hips, knees,and ankles. 1 = unable to raise extended legs, able to move knees and feet. 2= unable to raise extended leg or move knee; able to move feet.3= unable to move any part of the lower limbs), measurements included the onset (time from induction of spinal anesthesia till Bromage = 3) and duration (time from complete block till Bromage =0).motor block will be assessed every 2min, 4min , 6min ,8min , 10min , 20min , 40min , 60min , 80min , 100min , 120min 140min , 160min , 180min and 200mins .

Eligibility
Key inclusion criteria
1. ASA statuses I or II patients.
2. Aged between 20 and 60 years old.
3. Patients scheduled for elective lower limb surgery.
4. Both sexes.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal.
2. Hepatic or renal impairment.
3. Neuromuscular diseases.
4. History of opioid abuse.
5. History of allergy to anesthetic drugs.
6. Infection at the lumbar area.
7. Coagulopathies.
8. Increased intra cranial tension (ICP).
9. Cardiovascular & respiratory diseases.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2015
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment outside Australia
Country [1] 6598 0
Egypt
State/province [1] 6598 0

Funding & Sponsors
Funding source category [1] 290585 0
Hospital
Name [1] 290585 0
mansura university hospital
Country [1] 290585 0
Egypt
Primary sponsor type
Hospital
Name
mansura university hospital
Address
egypt
mansura university
faculty of medicine
egypt, Dakahlia governerate
Gihan street
Country
Egypt
Secondary sponsor category [1] 289274 0
None
Name [1] 289274 0
Address [1] 289274 0
Country [1] 289274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292224 0
the Medical Research Ethics Committee, Faculty of medicine, Mansura University.
Ethics committee address [1] 292224 0
Egypt
Mansura university
faculty of medicine
Mansura city,Dakahlia Governorate
Gihan street
Ethics committee country [1] 292224 0
Egypt
Date submitted for ethics approval [1] 292224 0
Approval date [1] 292224 0
13/08/2014
Ethics approval number [1] 292224 0

Summary
Brief summary
This is a randomized controlled trial (RCT) that will include 99 patients for elective lower limb surgery. This study will be conducted in Mansoura university hospitals.
Inclusion criteria:
1. ASA statuses I or II patients.
2. Aged between 20 and 60 years old.
3. Patients scheduled for elective lower limb surgery.
4. Both sexes
Exclusion criteria:
1. Patient refusal.
2. Hepatic or renal impairment.
3. Neuromuscular diseases.
4. History of opioid abuse.
5. History of allergy to anesthetic drugs.
6. Infection at the lumbar area.
7. Coagulopathies.
8. Increased intra cranial tension (ICP).
9. Cardiovascular & respiratory diseases
Patient preparation:
All patients will be visited a day prior to surgery. The general physical as well as systemic examination will be carried out. Basic demographic characters including age, sex, weight and height will be recorded. Routine investigations like haemoglobin, bleeding time, clotting time and complete urine examination, serum creatinine, blood sugar, chest X-ray, ECG and any other specific investigation wherever needed will be carried out.
A linear visual analogue scale (VAS) on a scale of 0-100mm (where 0 for no pain and 100 for worst possible pain) will be explained to each patient and consent to participate in the study will be obtained.
Anesthetic Considerations:
On arrival to the operating theater, routine monitoring including: heart rate, electrocardiogram, non-invasive blood pressure, and peripheral oxygen saturationand baseline values will be recorded. All patients will receive an intravenous preload of10ml/kg ringer solution before the subarachnoid block.

Randomization:
Patients will be randomly allocated to one of three groups (33 patients in each group) using closed envelop method.
Group F (n=33): patients will receive a premixed solution of 3 ml (0.5%) hyperbaric bupivacaine, 0.5 mL (25micro gram fentanyl) with 0.5 ml preservative free saline.
Group M(n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mLof 10% MgSO4 with 0.5 ml preservative free saline.
Group M + F (n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mL (25 micro gram) fentanyl with0.5 mL of 10% MgSO4.
Blinding will be achieved through the use of equal amounts of intrathecal drugs (4 mL) in identical syringes prepared by an anaesthetist not involved in the study. Spinal anesthesia will be conducted by an investigator who will be unaware of the identities of the drugs.

Technique of the neuroaxial block:
Lumbar puncture for the patients in the sitting position will be performed under complete aseptic conditions at L3-4 or L4-5 interspaces with a 25- gauge spinal needle using a midline approach. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, the premixed anesthetic solution will be injected.Immediately after intrathecal injection of the local anaesthetic, patients will be turned into the supine position. Oxygen 3 L/min was applied to all patients via nasal prongs. Surgery will be permitted after ensuring T8 sensory block to pin-prick.

Intraoperative Assessment:
Patients will be monitored with continuous ECG and pulse oximeter. Heart rate, oxygen saturation (SPO2), systolic, diastolic and mean arterial blood pressures will be monitored non-invasively at the baseline, immediately after block and then every 5 min for the first 30 min, and every 15mints till the end of surgery.
Bilateral sensory block to pinprick will be tested in a cephaladto caudal direction in the midclavicular line bilaterally, measurements included:the onset time to sensory block (time from intrathecal injection of drugs to reach T10 sensory level), the highest dermatomal level assessed by pin-prickexam, the time to two segments regression from the previous highest dermatomal level, and the duration of sensory block (time from the onset of sensory block till regression to S1).
Motor blockade of the lower extremity muscles will be assessed using Bromage Score: (0= no motor block, ability to raise hips, knees,and ankles. 1 = unable to raise extended legs, able to move knees and feet. 2= unable to raise extended leg or move knee; able to move feet.3= unableto move any partof the lower limbs), measurements included the onset (time from induction of spinal anesthesia till Bromage = 3) and duration (time from complete block till Bromage =0). Degree of motor block at the onset of sensory block and at the time of highest dermatomal level block. Sensory and motor block will be evaluated.post oprative the time and amount of post-operative analgesic requirement and the incidence of side effects will be assesssed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54178 0
Dr Mohamed Gad El Dosoky
Address 54178 0
mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet
Country 54178 0
Egypt
Phone 54178 0
+20 1093019320
Fax 54178 0
Email 54178 0
[email protected]
Contact person for public queries
Name 54179 0
Mohamed Gad El Dosoky
Address 54179 0
mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet
Country 54179 0
Egypt
Phone 54179 0
+20 1093019320
Fax 54179 0
Email 54179 0
[email protected]
Contact person for scientific queries
Name 54180 0
Mohamed Gad El Dosoky
Address 54180 0
mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet
Country 54180 0
Egypt
Phone 54180 0
+20 1093019320
Fax 54180 0
Email 54180 0
[email protected]

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