Clinical trial NCT02581683: Magnesium Sulfate in Adductor Canal Blocks
Official title: Does Magnesium Sulfate as a Supplement in Adductor Canal Blocks Improve Pain Control After Total Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthroplasty
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proper analgesia after total knee arthroplasty (TKA) is important for encouraging early ambulation, which can facilitate improved patient outcomes and early hospital discharge. For pain control after TKA, adductor canal blocks (ACBs) improve upon the gold standard femoral nerve blocks (FNBs) since they do not cause as much quadriceps muscle weakening, while providing equivalent analgesia. Multimodal analgesia has become commonplace as a method of superior pain control with fewer side effects. Magnesium sulfate as an adjuvant to FNB local anesthetics can improve pain control after surgery; however, it also prolongs time to ambulation. There are no reports on the effect of magnesium sulfate in ACBs on analgesia after TKA. Thus the purpose of this randomized, double-blind, controlled trial is to determine whether magnesium sulfate given with local anesthetics via ACB can prolong analgesia, reduce pain scores and opioid consumption, and increase mobilization in TKA patients.

Detailed description: Adequate analgesia after surgery is important for patient well-being, satisfaction, rapid recovery, and timely discharge. Due to our aging population, total knee arthroplasties (TKAs) are an increasingly common surgical procedure in Canada, with 57,718 performed in 2012-2013 alone. Improved functional outcomes and early hospital discharge are facilitated when patients ambulate within several hours of surgery. Early ambulation is enabled by good analgesia without concomitant muscle weakness or debilitating side effects associated with opioid consumption. Given the high volume of knee replacements, the need to ambulate early, and the importance of effective pain management, the development of new analgesia techniques for TKAs is an important endeavor to reduce hospital costs and improve the quality of life of a substantial number of patients.

In order to minimize adverse side effects while still providing adequate postoperative analgesia, many anesthesiologists now co-administer smaller doses of several different medications, which act additively or synergistically depending on their combined and varied mechanisms of action. Often these medications are given locally, either directly into the knee (periarticularly) or near the nerves innervating the knee, for example the femoral nerve block (FNB) or the adductor canal block (ACB).

FNBs, wherein local anesthetic medications are injected around the femoral nerve, are commonly used to manage pain following TKA. Although they assist in providing quality postoperative pain relief, FNBs are also associated with weakening of the quadriceps muscle, and an increased risk of falls. The ACB involves an injection of local anesthetics such as ropivacaine or bupivacaine into the adductor canal in the middle third of the thigh, which contains the sensory saphenous nerve. ACB is as effective as FNB at reducing postoperative pain in TKA patients. However, ACBs do not cause quadriceps weakening to the same extent as FNBs, and result in earlier recovery of ambulation after surgery compared to FNBs. Since ACBs produce less quadriceps weakening (due to their actions on sensory, rather than motor, nerves), this anesthetic technique may reduce the risk of falling in the postoperative period compared to FNBs; however, most studies are underpowered to detect this statistically.

Recent attention has been given to magnesium sulfate (MgSO4) as a supplement to improve and/or prolong local anesthesia postoperatively. MgSO4 is thought to reduce pain via antagonism of N-methyl-D-aspartate (NMDA) receptors. A local mechanism of action on peripheral rather than central NMDA receptors is supported by studies showing that despite providing pain relief, peripherally administered MgSO4 does not increase cerebrospinal fluid concentrations of magnesium, implying that it cannot cross the blood-brain barrier to enter the central nervous system.

In knee surgery patients, locally administered MgSO4 via the periarticular route reduces postoperative pain, reduces cumulative analgesic consumption, and prolongs analgesia. MgSO4 co-administered with local anesthetic via FNB in knee surgery patients reduces pain and postoperative analgesic consumption compared to local anesthetic alone; however, it also prolongs the time to ambulation, which could delay hospital discharge. Currently, there are no investigations into the analgesic efficacy of MgSO4 administered via ACB in TKA patients. Therefore, the purpose of this randomized controlled trial is to assess the duration of analgesia in TKA patients receiving ACBs with or without MgSO4. The investigators hypothesize that patients receiving MgSO4 will have prolonged analgesia, improved pain scores, and will be able to mobilize further, all of which will contribute to a shorter hospital length of stay in these patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification score of 1 to 3
* Presenting for unilateral primary total knee arthroplasty
* age 18 to 85

Exclusion Criteria:

* inability to use a patient-controlled analgesia pump
* long-standing use of opioid medications (3 months or longer)
* history of chronic pain syndromes
* significant cardiovascular disease
* medical conditions that preclude the use of a regional anesthetic technique or any of the study drugs
* inability to read and understand English
* incompetent to give consent to study participation
* women who are pregnant or nursing

Primary outcomes:
measure: Time to first analgesic request
timeFrame: First occurrence during hospitalization (up to 72 hours postoperatively)
Secondary outcomes:
measure: Cumulative morphine consumption
timeFrame: Cumulative dose during the first 24 postoperative hours
measure: Number of steps taken
timeFrame: Number of steps taken during postoperative days 1 and 2
measure: Pain
timeFrame: 2, 4, 8, 12, and 24 hours after adductor canal injection (or sham)
measure: Patient satisfaction
timeFrame: Once, 24 hours after surgery
measure: Time to readiness for discharge
timeFrame: Once, upon occurrence, within 72 hours after surgery
measure: Length of stay
timeFrame: Once, within 72 hours after surgery
measure: Side effects
timeFrame: Upon occurrence, up to 72 hours after surgery
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Vidur Shyam, MBBS, FRCPC
role: PRINCIPAL_INVESTIGATOR
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