The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

Pain Clinical Trial

Official title:

The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433081
• Other study ID #: STU00032878
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: February 19, 2014
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic implications(2).More importantly, postoperative pain can lead to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications that might decrease postoperative pain is therefore highly desirable.

Some medications such as lidocaine and ketamine have been proved to decrease postoperative pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still unknown if those medications can in fact lead to a better quality of recovery .

Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA) receptor(5). NMDA receptors have an important role on pain modulation (6). The use of Intraoperative magnesium in order to decrease postoperative pain had contradictory results in different studies. Some studies have shown a potential benefit of magnesium in decreasing postoperative pain (7,8) while others have not demonstrated any benefit (9,10).

In the ambulatory setting, specifically, Tramer et al. did not find any improvement on postoperative pain after an Intraoperative dose of magnesium for patients undergoing ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery (12).

Even though, the reduction of postoperative opioid requirement has been used in many studies in the ambulatory literature, it has been recently questioned by some investigators (13).Patients might take more opioid medications but they may not necessarily develop opioid related side effects such as nausea and vomiting. A more global evaluation of the patient involving several aspects of recovery would be more significant.

The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a useful outcome measure to assess the impact on changes in health care delivery (15), but anesthesia studies underutilize this instrument.

As more complex and painful procedures are being done in the ambulatory setting , the use of non-opioid strategies to control postoperative pain and to enhance quality of recovery will have even a greater role in the anesthetic management of patients. Magnesium has not been established as a potential adjuvant in ambulatory patients with conflicting results of previous investigators. The main objective of this study is to evaluate if the Intraoperative use of magnesium have the ability to improve postoperative quality of recovery in ambulatory patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• undergoing lumpectomy

• ASA I and II

• Age between 18-64

Exclusion Criteria:

• pregnancy

• breastfeeding -history of EKG abnormalities-

• kidney disease including: End Stage Renal Disease and polycystic kidney disease

• unable to understand the informed consent

• use of opioid in the last week

• use of calcium channel blockers

• Drop-out: surgeon or patient request

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Opioid Use, Unspecified, Uncomplicated
• Pain

Intervention

Drug:
• Placebo infusion of .9 normal saline
administration of .9 normal saline
• administration of magnesium sulfate
administration of magnesium sulfate

Locations

Country	Name	City	State
United States	Prentice Womens Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-40, table of contents. — View Citation

Begon S, Pickering G, Eschalier A, Mazur A, Rayssiguier Y, Dubray C. Role of spinal NMDA receptors, protein kinase C and nitric oxide synthase in the hyperalgesia induced by magnesium deficiency in rats. Br J Pharmacol. 2001 Nov;134(6):1227-36. — View Citation

Berti M, Baciarello M, Troglio R, Fanelli G. Clinical uses of low-dose ketamine in patients undergoing surgery. Curr Drug Targets. 2009 Aug;10(8):707-15. Review. — View Citation

Mayer ML, Westbrook GL, Guthrie PB. Voltage-dependent block by Mg2+ of NMDA responses in spinal cord neurones. Nature. 1984 May 17-23;309(5965):261-3. — View Citation

McKay A, Gottschalk A, Ploppa A, Durieux ME, Groves DS. Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery. Anesth Analg. 2009 Dec;109(6):1805-8. doi: 10.1213/ANE.0b013e3181be371b. — View Citation

Ryu JH, Kang MH, Park KS, Do SH. Effects of magnesium sulphate on intraoperative anaesthetic requirements and postoperative analgesia in gynaecology patients receiving total intravenous anaesthesia. Br J Anaesth. 2008 Mar;100(3):397-403. doi: 10.1093/bja/aem407. — View Citation

White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery Scores Post Operative	Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).	24 hours post operative	No
Secondary	Opioid Consumption	Opioid consumption after discharge	24 hours	No