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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]

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

Condition category

Condition code

Anaesthesiology

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]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

fentanyl group (f) group

Control group

Active

Outcomes

Primary outcome [1]

duration of spinal anesthesia

Timepoint [1]

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]

onset and time of sensory block .

Timepoint [1]

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]

The time and amount of post-operative analgesic requirement

Timepoint [2]

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]

The incidence of side effects.

Timepoint [3]

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]

onset and duration of motor block.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

mansura university hospital

Address [1]

egypt,mansura,Dakahlia Governorate ,Gihan street

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

the Medical Research Ethics Committee, Faculty of medicine, Mansura University.

Ethics committee address [1]

Egypt 
Mansura university 
faculty of medicine 
Mansura city,Dakahlia Governorate 
Gihan street

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

Approval date [1]

13/08/2014

Ethics approval number [1]

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

Dr Mohamed Gad El Dosoky

Address

mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet

Country

Egypt

Phone

+20 1093019320

Fax

dr_mohamedgad2000@yahoo.com

Contact person for public queries

Name

Mohamed Gad El Dosoky

Address

mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet

Country

Egypt

Phone

+20 1093019320

Fax

dr_mohamedgad2000@yahoo.com

Contact person for scientific queries

Name

Mohamed Gad El Dosoky

Address

mansura university, faculty of medicine ,Egypt .
egypt,mansura,Dakahlia Governorate
gihan sreet

Country

Egypt

Phone

+20 1093019320

Fax

dr_mohamedgad2000@yahoo.com

No information has been provided regarding IPD availability

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No Supporting Document Provided

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