Perioperative Ketamine for Pain With Gastric Bypass

Mayo Clinic34 enrolled

Overview

Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea. Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laparoscopic Gastric Bypass Surgery Ketamine

Interventions

Standard therapyDRUG

Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses. Other standard surgical post-op care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona 2. BMI is ≥ 35 kg/m2 3. Consent is able to be obtained as per Mayo Clinic policy Exclusion Criteria: 1. Intolerance to ketamine 2. History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features 3. Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke) 4. Presence of acute elevation of intracranial or intraocular pressure 5. Presence of seizure disorder 6. History of substance abuse or addiction 7. Creatinine greater than 1.5 mg/dL 8. End-stage liver disease 9. Pregnancy 10. Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.

Outcomes

Primary Outcomes

Total Cumulative Perioperative Opioid Dose

Measured in oral morphine equivalents

Time frame: approximately 48 hours after induction of anesthesia

Secondary Outcomes

Average Pain Score 0-12 Hours

Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Time frame: approximately 0-12 hours post operatively

Average Pain Score 12-24 Hours

Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Time frame: approximately 12-24 hours post operatively

Average Pain Score 24-48 Hours

Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Time frame: approximately 24-48 hours post operatively

Post-Operative Nausea

Number of subject to experience post-operative nausea

Time frame: 12 hours, 24 hours, and 48 hours

Length of Stay in Hospital

Length of hospital stay measured in hours

Time frame: Arrival at hospital until discharge from hospital, approximately 2 days

Patient Satisfaction With Pain Control at Time of Hospital Discharge

Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.

Time frame: approximately 1-2 days post-operatively

Patient Satisfaction With Pain Control at Postoperative Visit

Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.

Time frame: approximately 30 days post-operatively