Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, randomized, double-blind study will enroll nonsmoking female subjects
      undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this
      study is that female nonsmokers who receive nicotine via nasal spray immediately before
      waking up from anesthesia will need less pain medications 24 hours after the surgery compared
      to the subjects who receive placebo spray.
    

Detailed description: 
      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.
    

Intervention name(s): Nasal Nicotine Spray; Nasal Normal Saline Spray
Intervention type(s): Drug; Drug
Intervention description(s): Single 3 mg dose of nasal nicotine spray; An isotonic solution of sodium chloride 0.65% in deionized water
Other intervention name(s): Nicotrol NS; Rhino-Mist; Salinex; Ocean Nasal Spray
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nicotine; Postoperative pain; Bariatric surgery