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Trial registered on ANZCTR


Registration number
ACTRN12612000001897
Ethics application status
Approved
Date submitted
15/12/2011
Date registered
3/01/2012
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intraoperative magnesium infusion as an adjuvant to
bilateral single-injection thoracic paravertebral block
for laparoscopic cholecystectomy
Scientific title
the use of magnesium sulfate infusion as an adjuvant to
thoracic paravertebral block for laparoscopic cholecystectomy decreases postoperative fentanyl consumption. a randomized, double blind,controlled trial.
Secondary ID [1] 273568 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the postoperative period following laparoscopic cholesyctectomy 285400 0
Condition category
Condition code
Anaesthesiology 285554 285554 0 0
Anaesthetics
Surgery 285591 285591 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients undergoing laparoscopic cholecystectomy were given bilateral single injection thoracic paravertebral block at the level of T5 with 25ml of 0.25% bupivacaine. Before induction of general anaesthesia, Group M (magnesium group) received a loading dose of magnesium sulphate 30 mg per kg in 100 ml of normal saline over 10 min followed by an infusion of 10 mg per kg per h till the end of surgery. Control group (group C) received the same volume of normal saline as a loading dose followed by a continuous infusion.
Intervention code [1] 283870 0
Treatment: Drugs
Comparator / control treatment
before induction of general anaesthesia, Control group (group C) received the same volume of normal saline as a loading dose followed by a continuous infusion.
Control group
Placebo

Outcomes
Primary outcome [1] 286145 0
postoperative fentanyl consumption.
In PACU and surgical ward, pain intensity was assessed by nurses who were blinded to the treatment group using a VAS at rest (VAS-R) and after movement {coughing or changing sides on the first postoperative day and walking on the second postoperative day}(VAS-M). The first analgesic medication was administered when the VAS-R exceeds 3 cm. Intravenous fentanyl 25 microgram at 10 min interval was titrated until the VAS decreased to less than 3 cm at which time, fentanyl consumption was recorded and the patients had access to a PCA device. This device was set to deliver fentanyl 10 microgram as an i.v bolus with a lockout interval of 10 min, without background infusion. Patients were advised to push the analgesic-demand button when they felt pain, and to repeat till pain relief. This PCA regimen was discontinued when no longer needed and replaced by oral analgesics. Cumulative doses of fentanyl given by PCA were recorded at 12, 24 and 36 h postoperatively.
Timepoint [1] 286145 0
at 12,24,36h postoperative.
Secondary outcome [1] 295232 0
postoperative visual analogue pain score
Timepoint [1] 295232 0
Pain scores were recorded using a VAS scale every 30 min during the first 2 h, every 2h during the next 10 h and every 4 h during the next24 hours postoperatively
Secondary outcome [2] 295233 0
The presence of nausea and vomiting.
The presence of nausea and vomiting was noted using a four-point scale (0=no nausea or vomiting, 1=mild nausea, 2=severe nausea, 3=retching or vomiting). Patients with a nausea score of 2 or 3 were initially given an i.v. bolus of metoclopramide 10 mg followed by ondansteron 4 mg if this was unsuccessful.
Timepoint [2] 295233 0
at 12,24,36h postoperative.

Eligibility
Key inclusion criteria
ASA I-II patients scheduled for laparoscopic cholecystectomy.
Minimum age
20 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of cardiovascular disease or conduction disturbance, if they had impaired renal, hepatic or pulmonary functions, neuromuscular disease, coagulation disorder, obesity (body mass index >35kg.m2), a known allergy to magnesium sulphate, opioids or any other drug used in the study, or inability to use the patient-controlled analgesia (PCA) system).

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)
Patients were randomized, by using a computer generated random list to one of two groups; before induction of general anesthesia.
a person (who was unaware of the assigned group) determinded the eligiblity of the patient to participate in the study. when this decision was made, the patient was then allocated to the assigned group according to his number in the computer generated random list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomized, by using a computer generated random list to one of two groups; before induction of general anesthesia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
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] 4003 0
Saudi Arabia
State/province [1] 4003 0
eastern province

Funding & Sponsors
Funding source category [1] 284379 0
Hospital
Name [1] 284379 0
King Abdullaziz Naval Base Hospital
Address [1] 284379 0
king abdullaziz naval base hospital, jubail 31951.
P.O.Box413
Country [1] 284379 0
Saudi Arabia
Primary sponsor type
Individual
Name
dr. waleed abdelmageed
Address
king abdullaziz naval base hospital, jubail 31951.
P.O.Box413
Country
Saudi Arabia
Secondary sponsor category [1] 283312 0
None
Name [1] 283312 0
Address [1] 283312 0
Country [1] 283312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286337 0
Hospital Ethics Committee
Ethics committee address [1] 286337 0
king abdullaziz naval base hospital , jubail 31951.
P.O.Box413
Ethics committee country [1] 286337 0
Saudi Arabia
Date submitted for ethics approval [1] 286337 0
17/01/2010
Approval date [1] 286337 0
12/03/2010
Ethics approval number [1] 286337 0
002

Summary
Brief summary
Background: Magnesium has antinociceptive effects. This study was designed to examine whether intraoperative administration of i.v magnesium with bilateral thoracic paravertebral block (PVB) enhances postoperative analgesia while reducing opioid consumption and opioid-related side effects.

Methods: In this prospective randomized, double-blinded, controlled study, 59 patients undergoing laparoscopic cholecystectomy were given bilateral single injection PVB at the level of T5. Before induction of general anaesthesia, patients were assigned to two groups. Group M (magnesium group) received a loading dose of magnesium sulphate 30 mg per kg in 100 ml of normal saline over 10 min followed by an infusion of 10 mg per kgper h till the end of surgery. Control group (group C) received the same volume of normal saline as a loading dose followed by a continuous infusion. In both groups, postoperative pain was initially controlled by i.v. fentanyl titration and then fentanyl PCA. Cumulative PCA fentanyl consumption, pain intensities, sedation scores, cardiovascular and respiratory variables and opioid-related adverse effects were recorded for 36 h after operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33516 0
Address 33516 0
Country 33516 0
Phone 33516 0
Fax 33516 0
Email 33516 0
Contact person for public queries
Name 16763 0
Dr.Walid Abd El Mageed
Address 16763 0
King Abdullaziz Naval Base Hospital, Jubail 31951 P.O.Box :413
Country 16763 0
Saudi Arabia
Phone 16763 0
+966557189366
Fax 16763 0
Email 16763 0
walidabdelmageed@yahoo.com
Contact person for scientific queries
Name 7691 0
Dr.Walid Abd El Mageed
Address 7691 0
King Abdullaziz Naval Base Hospital, Jubail 31951 P.O.Box :413
Country 7691 0
Saudi Arabia
Phone 7691 0
+966557189366
Fax 7691 0
Email 7691 0
walidabdelmageed@yahoo.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary