Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries

NCT02508857 | Completed Phase 4 DMC

• 1 other identifier: NP0792010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium sulfate has been reported to improve postoperative pain, but evidence is still controversial. Some studies demonstrated benefits while others concluded that there is no efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods: We designed a double-blind randomized controlled trial that compared intravenous magnesium sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and opioid related side effects.

Conditions

Pain, Postoperative

Keywords

pain, postoperative; anesthesia adjuvants; magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  intensity of pain in the patients using numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain

  24 hours

Secondary Outcomes (2)

• time to first morphine rescue

  first 6 hours

• morphine consumption

  60 minutes

Study Arms (3)

ketorolac

ACTIVE COMPARATOR

intravenous ketorolac (30 mg) is injected in bolus, followed by continuous infusion of saline solution (Group K) during the surgical procedure

Drug: Ketorolac

magnesium

EXPERIMENTAL

intravenous magnesium sulfate (20 mg/kg) is injected in bolus, followed by continuous infusion of magnesium sulfate (2 mg/kg/h) (Group M) during the surgical procedure

Drug: Magnesium

saline

PLACEBO COMPARATOR

intravenous saline solution (20 ml) is injected in bolus, followed by continuous infusion of saline infusion during the entire procedure (Group S).

Drug: Saline solution

Interventions

Ketorolac DRUG

Patients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K),

Also known as: Toradol

ketorolac

Magnesium DRUG

Patients received intravenous magnesium sulfate (20 mg/kg) in bolus, then magnesium sulfate (2 mg/kg/h) was continuously injected during the procedure (Group M)

Also known as: Magnesium sulfate

magnesium

Saline solution DRUG

intravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S).

Also known as: Sodium chloride

saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II female patients undergoing laparoscopic gynecologic oncology surgeries, for treatment of cancer

You may not qualify if:

• chronic pain, cardiovascular, hepatic or renal disease, neuromuscular disease, diabetes, drugs or alcohol abuse, obesity, patients treated with calcium channel blockers or magnesium, allergy or contraindication to any of the drugs studied.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Angela Maria Sousa

São Paulo, São Paulo, 01403010, Brazil

Location

Related Publications (2)

• Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.

  PMID: 23121612 RESULT

• De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.

  PMID: 23669270 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Magnesium; Magnesium Sulfate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• angela m sousa, phD

  Cancer Institute of the State of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: July 27, 2015
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

BR (1)