Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Status: | Completed |
---|---|
Conditions: | Chronic Pain, Smoking Cessation, Hospital |
Therapuetic Areas: | Musculoskeletal, Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 7/11/2015 |
Start Date: | September 2010 |
End Date: | April 2015 |
A Randomized, Double Blind, Study to Evaluate the Efficacy of Nasal Nicotine Spray to Reduce Post-Operative Opioid Requirements in Nonsmokers in Elective Laparoscopic Bariatric Surgical Patients
Though nicotine is known to be a mild analgesic, its use in the peri-operative period to
reduce postoperative opioid requirements has only recently been investigated. In nonsmokers
it has been shown to reduce postoperative pain and opioid requirements in both female
patients undergoing uterine surgery and male patients undergoing prostatectomy. We have
recently confirmed these findings in women undergoing uterine surgery by open, laparoscopic
and vaginal approaches. In this study we found a 30% mean reduction of 24 hour
postoperative opioid requirements following the administration of a 3 mg dose of nicotine
nasal spray. Two previous studies with perioperative transdermal nicotine found that
increasing doses of nicotine and increasing serum levels of nicotine were associated with
higher rates of nausea. In our study, we found that the administration of nasal nicotine
was associated with a transient increase of postoperative nausea and vomiting (PONV), but
this was limited to the recovery room (PACU) stay. Two studies of nasal nicotine where
antiemetics were prophylactically administered did not report the incidence of nausea. In
our study, antiemetics were used as rescue medications only. Thus, it is unclear if the
prophylactic administration of anti-emetics would effectively counteract the transient
emetogenic effect of a small dose of nasal nicotine.
Laparoscopic bariatric surgery is becoming an increasingly popular treatment of morbid
obesity. We recently performed a detailed analysis of postoperative pain and opioid
requirements among patients that had this type of surgery and found that among non-smokers
severe pain (pain >7/10 on a 10 point scale) was commonly experienced (35%) despite
substantial amount of postoperative opioid use (mean 68 mg oral morphine equivalents) and
non-opioid analgesics in the first 24 hours. Because obesity related sleep disorders exceed
70% of patients undergoing bariatric surgery, and those disorders are exacerbated by
opioids, potential therapies that could reduce postoperative opioid requirements in these
patients have substantial value. Further, delayed nausea often poses a problem for these
patients meeting hospital discharge criteria, and opioids used for analgesia aggravates this
problem. Thus, the use of nasal nicotine could reduce the amount of opioid these patients
require for postoperative analgesia. Combined with aggressive antiemetic prophylaxis
against PONV, nasal nicotine could paradoxically and indirectly reduce the incidence of
nausea in these patients by decreasing postoperative opioid requirements. The proposed
study is a randomized clinical trial examining how nicotine affects recovery of female
non-smokers undergoing bariatric surgery from general anesthesia. We will test the
hypothesis that nicotine, administered in a nasal spray immediately before emergence from
anesthesia, will reduce postoperative opioid requirement and postoperative pain. A
secondary outcome is to assess if the routine administration of prophylactic antiemetic
therapy prevents increased PONV associated with nicotine administration.
reduce postoperative opioid requirements has only recently been investigated. In nonsmokers
it has been shown to reduce postoperative pain and opioid requirements in both female
patients undergoing uterine surgery and male patients undergoing prostatectomy. We have
recently confirmed these findings in women undergoing uterine surgery by open, laparoscopic
and vaginal approaches. In this study we found a 30% mean reduction of 24 hour
postoperative opioid requirements following the administration of a 3 mg dose of nicotine
nasal spray. Two previous studies with perioperative transdermal nicotine found that
increasing doses of nicotine and increasing serum levels of nicotine were associated with
higher rates of nausea. In our study, we found that the administration of nasal nicotine
was associated with a transient increase of postoperative nausea and vomiting (PONV), but
this was limited to the recovery room (PACU) stay. Two studies of nasal nicotine where
antiemetics were prophylactically administered did not report the incidence of nausea. In
our study, antiemetics were used as rescue medications only. Thus, it is unclear if the
prophylactic administration of anti-emetics would effectively counteract the transient
emetogenic effect of a small dose of nasal nicotine.
Laparoscopic bariatric surgery is becoming an increasingly popular treatment of morbid
obesity. We recently performed a detailed analysis of postoperative pain and opioid
requirements among patients that had this type of surgery and found that among non-smokers
severe pain (pain >7/10 on a 10 point scale) was commonly experienced (35%) despite
substantial amount of postoperative opioid use (mean 68 mg oral morphine equivalents) and
non-opioid analgesics in the first 24 hours. Because obesity related sleep disorders exceed
70% of patients undergoing bariatric surgery, and those disorders are exacerbated by
opioids, potential therapies that could reduce postoperative opioid requirements in these
patients have substantial value. Further, delayed nausea often poses a problem for these
patients meeting hospital discharge criteria, and opioids used for analgesia aggravates this
problem. Thus, the use of nasal nicotine could reduce the amount of opioid these patients
require for postoperative analgesia. Combined with aggressive antiemetic prophylaxis
against PONV, nasal nicotine could paradoxically and indirectly reduce the incidence of
nausea in these patients by decreasing postoperative opioid requirements. The proposed
study is a randomized clinical trial examining how nicotine affects recovery of female
non-smokers undergoing bariatric surgery from general anesthesia. We will test the
hypothesis that nicotine, administered in a nasal spray immediately before emergence from
anesthesia, will reduce postoperative opioid requirement and postoperative pain. A
secondary outcome is to assess if the routine administration of prophylactic antiemetic
therapy prevents increased PONV associated with nicotine administration.
Lifelong, non-smoking female patients undergoing bariatric surgery.
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