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Patient Safety Tip
of the Week
February 25, 2020
More on
Perioperative Gabapentinoids
Gabapentinoids have increasingly
been used as an adjunct for analegesia in a variety
of surgical procedures. They have been promoted as part of multimodal analgesia
regimens intended to reduce the use of opioids. In our February 11, 2020
Patient Safety Tip of the Week “ERAS Rocks!” we
noted that many ERAS (Enhanced Recovery After Surgery) protocols use them but
we inserted our own warning about their use. Over the past 3 years we have done
several columns on patient safety issues related to gabapentinoids
(see list below).
In fact, a recent systematic review and meta-analysis on
perioperative use of gabapentinoids (Verret
2019) found no clinically significant analgesic effect for the
perioperative use of gabapentinoids, with low level
of evidence, and an increased risk of adverse events with moderate level of
evidence. The authors concluded that their results do not support the use of gabapentinoids for the management postoperative acute pain
in adult patients.
Duke University researchers have also
taken a look at the impact of gabapentinoids
used in the perioperative period. Ohnuma et al. (Ohnuma 2019)
analyzed data from a large administrative claims database, including 862,524
patients from 592 hospitals, who underwent elective primary THA or TKA between
2009 and 2014. They looked at the following drugs, alone or in combination, on
the day of surgery for patients undergoing TKA or THA: acetaminophen,
nonsteroidal anti-inflammatory drugs (NSAID’s), gabapentinoids
(gabapentin or pregabalin), or none of the three drugs.
Compared to none of the three drugs as the reference
category, exposure to gabapentinoids was associated
with increased odds of naloxone use after surgery (OR 2.11), noninvasive
ventilation (OR, 1.45), invasive mechanical ventilation (OR 1.25), and ICU
admission (OR 1.28). A similar increase was seen in analgesic combinations
including gabapentinoids. The group receiving NSAID’s
plus acetaminophen showed the most protective associations with naloxone use
after surgery (OR 0.59), invasive mechanical ventilation (OR, 0.72), and ICU admission
(OR 0.69), and was associated with the lowest opioid consumption on the day
before discharge.
The authors conclude that preoperative gabapentinoids
were associated with significant increased risk of postoperative opioid-related
respiratory depression. It also failed to find benefits for gabapentinoids
in terms of postoperative opioid consumption and LOS. They recommend
reconsideration of routine use of preoperative gabapentinoids
in the adult TKA and THA population.
The researchers also looked at 108,616 patients who
underwent elective colorectal surgery across the 605 hospitals, 2% of whom received
gabapentinoids on the day of surgery (Yan 2019). They
found that use of gabapentinoids was associated with
higher odds of noninvasive ventilation (OR 1.39) and receipt of naloxone after
surgery (OR 1.70). There was no difference in invasive mechanical ventilation,
opioid consumption, or LOS. They cite other small studies showing increased risk
of postoperative respiratory depression and naloxone use in patients receiving gabapentinoids, which may be explained by an interaction
between gabapentinoids and opioids.
Our January 2020 What's
New in the Patient Safety World column “FDA Warning on Gabapentinoids” summarized some of our previous concerns about gabapentinoids
and discussed a new warning on gabapentinoids from
the FDA (FDA 2019).
The FDA warns that “serious breathing
difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin
(Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of
opioid pain medicines and other drugs that depress the central nervous system,
and conditions such as chronic obstructive pulmonary disease (COPD) that reduce
lung function. The elderly are also at higher risk.”
The FDA notes that gabapentinoids are often being combined with CNS
depressants (including opioids, anti-anxiety medicines, antidepressants, and
antihistamines), which increases the risk of respiratory depression. It
acknowledges that there is less evidence supporting the risk of serious
breathing difficulties in healthy individuals taking gabapentinoids
alone.
The FDA decision was
based upon both reports it received and studies in the medical literature. Of
fatal cases involving gabapentinioids reported to the
FDA, all had at least one additional risk factor.
Keep in mind that
the above data are not from randomized controlled trials (the FDA did review two
RCT’s in healthy people), It’s doubtful that RCT’s will be conducted on the use
of gabapentinoids in this setting. But, in the
absence of hard evidence for their efficacy in analgesia for perioperative
pain, it’s probably wise to exclude them from your protocols.
Gabapentinoids have been very valuable in the management of
chronic neuropathic pain. But it appears they add little or no benefit to
management of perioperative pain and they add additional risks.
Some of our prior columns on safety issues with gabapentinoids:
- November 2017 “Bad Combination:
Gabapentin and Opioids”
- March 2019 “Gabapentin and
Pregabalin on the Radar Screen”
- January 2020 “FDA Warning on Gabapentinoids”
References:
Verret M, Lauzier F, Zarychanski R, et al. Perioperative
Use of Gabapentinoids for the Management of
Postoperative Acute Pain: A Systematic Review and Meta-analysis. 2019 annual
meeting of the American Society of Anesthesiologists (ASA; abstract A2096).
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=18&absnum=1927
OhnumaT,
Raghunathan K, Ellis A, et al. Abstract S-344 Effects of Acetaminophen, NSAID’s,
Gabapentinoids and Their Combinations on the Day of
Surgery in Total Hip and Knee Arthroplasties. Anesthesia & Analgesia 2019;
128(5): 741
https://iars.app.box.com/v/AM19AbstractSupplement
Yan R, Ohnuma T, Krishnamoorthy V, et al. Abstract S-353 Gabapentinoids on the Day of Colorectal Surgery Are
Associated with Adverse Postoperative Respiratory Outcomes. Anesthesia &
Analgesia 2019; 128(5): 760
https://iars.app.box.com/v/AM19AbstractSupplement
FDA (US Food and
Drug Administration). FDA warns about serious breathing problems with seizure
and nerve pain medicines gabapentin (Neurontin, Gralise,
Horizant) and pregabalin (Lyrica, Lyrica CR)When used with CNS depressants or in patients with lung
problems. FDA 2019; 12-19-2019
https://www.fda.gov/media/133681/download
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