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Trial registered on ANZCTR


Registration number
ACTRN12609000182291
Ethics application status
Approved
Date submitted
1/02/2009
Date registered
17/04/2009
Date last updated
17/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of preemptive intravenous low dose magnesium sulphate on early postoperative pain after laparoscopic cholecystectomy
Scientific title
Randomised controlled trial of the effect of intravenous low dose magnesium sulphate on early postoperative pain after laparoscopic cholecystectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early postoperative pain after laparoscopic cholecystectomy 4257 0
Condition category
Condition code
Anaesthesiology 4479 4479 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients that satisfy inclusion criteria will be randomly allocated in three groups. In two groups patients will receive magnesium sulphate intravenously in two different dosages once, after anaesthesia induction, prior to surgical incision. One group will receive intravenous bolus 5 mg/kg body weight magnesium sulphate and second group intravenous bolus 7.5 mg/kg body weight magnesium sulphate prior to surgical incision. Magnesium sulphate will be given slowly intravenously, bolus dose in 60 seconds, in both groups. The anaesthetic management of patients will be standardized. All patients will be premedicated with peroral midazolam (7.5 mg) 45 minutes before surgery. Anaesthesia will be induced with midazolam 0.2 mg/kg and propofol 1.5 mg/kg followed by vecuronium 0.1 mg/kg to facilitate tracheal intubation. Fentanyl in dose of 3 µg/kg will be given before surgical incision and nasogastric tube will be inserted for the duration of procedure. The lungs will be mechanically ventilated with oxygen/nitrous oxide, keeping the end-tidal carbon dioxide between 35 – 40 mmHg. Throughout the procedure, intravenous infusion of 500 - 1.000 ml of Ringer solution will be administered and in case of inadequate muscle relaxation, intermittent bolus of vecuronium 0.04 mg/kg will be added. During laparoscopy, intraabdominal pressure will be maintained at 12 mmHg. Troacar insertion sites would not be infiltrated with local anaesthetic, neither intraperitoneal local anaesthetic will be administered. Postoperative pain would be assesed at rest using visual analog scale (VAS) starting from 0 = no pain at all to 10 = worst pain imaginable. The intensity of postoperative pain would be assessed by an investigator blinded to the patient group. Assessment will be made at 1st,2nd, 3rd, 6th, 9th and 24th postoperative hour. According to score on VAS scale, a bolus dose of intravenous analgesic will be administered. If VAS scores will be 3 or 4, methamizol 2.5g intravenously would be given, if VAS scores will be 5 – 7, diclofenac 75 mg intravenously and if VAS scores will be 8-10, tramadol 1mg/kg body weight intravenously would be given, respectively.
Intervention code [1] 3979 0
Prevention
Comparator / control treatment
Patients in control group will not receive magnesium sulphate prior to surgical incision. Patients in control group will receive 10 ml of saline slowly (in 60 seconds), intravenously,only once in bolus dose prior to surgical incision.The intensity of postoperative pain will be assessed same way as in intervention groups, by an investigator blinded to the patient group. Assessment will be at 1st,2nd, 3rd, 6th, 9th and 24th postoperative hour. According to score on (visual analog scale) VAS scale, a bolus dose of intravenous analgesic will be administered. If VAS scores will be 3 or 4 methamizol 2.5g iv will be given, if VAS scores will be 5 – 7, diclofenac 75 mg iv and if VAS scores will be 8-10, tramadol 1 mg/kg body weight will be given.
Control group
Placebo

Outcomes
Primary outcome [1] 5359 0
severity of early postoperative pain assessed on visual analog scale ( VAS )
Timepoint [1] 5359 0
first three postoperative hours,every hour, at 1st, 2nd and 3rd postoperative hour
Secondary outcome [1] 9009 0
analgesic consumption in 24 postoperative hours,according to pain score on VAS (visual analog scale) patients will be given analgesic intravenously and the whole consumption in 24 hours would be summed by an investigator
Timepoint [1] 9009 0
first 24 postoperative hours, at 1st,2nd,3rd,6th, 9th and 24th postoperative hour

Eligibility
Key inclusion criteria
patients ASA ( American Society of Anesthesiologists ) I-II undergoing elective laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindications to any of the drug used in trial, preexisting neurological or psychiatric illness and hystory of drug and alcochol abuse

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)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
21/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1553 0
Croatia
State/province [1] 1553 0
Country [2] 1554 0
Croatia
State/province [2] 1554 0

Funding & Sponsors
Funding source category [1] 4436 0
Self funded/Unfunded
Name [1] 4436 0
Iva Bacak Kocman
Country [1] 4436 0
Croatia
Funding source category [2] 4727 0
Self funded/Unfunded
Name [2] 4727 0
Country [2] 4727 0
Croatia
Primary sponsor type
Individual
Name
Iva Bacak Kocman
Address
Brace Slukan 17
42 000 Varazdin
Croatia
Country
Croatia
Secondary sponsor category [1] 3997 0
None
Name [1] 3997 0
Address [1] 3997 0
Country [1] 3997 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Laparoscopic cholecystectomy is a gold standard in treating symptomatic cholelithiasis. One of the major advantages over open cholecystectomy is reduced postoperative pain, although pain still remains the most prevalent complaint in early postoperative hours after laparoscopy.
Overall pain after laparoscopic cholecystectomy is, according to localization, divided in three major components: incisional pain (somatic pain), visceral pain (deep intraabdominal pain) and shoulder pain. Incisional pain dominates and is most intense on the day of surgery and on the following day. Interventions before noxious stimulus causing central sensitization may attenuate or block sensitization and reduce acute pain and analgesic consumption.
Magnesium, the fourth most common cation in human body is a calcium channel blocker and regulates calcium influx in the cell. N – methyl – D – aspartate (NMDA) receptor is an ionotropic receptor for glutamate and aspartate situated throughout brain and spinal cord and is modulated by a number of endogenous and exogenous compounds. NMDA receptor blockade prevents induction of central sensitization due to peripheral nociceptive stimulation and abolishes the hypersensitivity once it is established. Magnesium is a noncompetitive antagonist of the NMDA receptors and its associated ion channels, and therefore very effective drug in treatment of postoperative pain.

The aim of this prospective, randomized study is to determine the effect of two preemptive intravenous low-doses of magnesium sulphate (7.5 mg/kg and 5.0 mg/kg) on early postoperative pain (during the first three hours after surgery) in patients with symptomatic cholelithiasis undergoing laparoscopic cholecystectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29237 0
Address 29237 0
Country 29237 0
Phone 29237 0
Fax 29237 0
Email 29237 0
Contact person for public queries
Name 12484 0
Iva Bacak Kocman
Address 12484 0
Brace Slukan 17
42 000 varazdin
Country 12484 0
Croatia
Phone 12484 0
+385 98 605 863
Fax 12484 0
Email 12484 0
[email protected]
Contact person for scientific queries
Name 3412 0
Iva Bacak Kocman
Address 3412 0
Brace Slukan 17
42 000 Varazdin
Country 3412 0
Croatia
Phone 3412 0
+385 98 605 863
Fax 3412 0
Email 3412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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