Multimodal Analgesia Effect on Post Surgical Patient
Phase 4
Completed
- Conditions
- Obesity, MorbidSurgeryBariatric Surgery Candidate
- Interventions
- Registration Number
- NCT04240626
- Lead Sponsor
- University of California, Davis
- Brief Summary
Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed
- Detailed Description
Pain control after weight loss surgery is challenging due to the alteration of digestive system anatomy and limitation on using medications which can either be crushed or in liquid form for the first 10 days to 14 days after surgery. Additionally there are multiple programs in place to eliminate the use of narcotic/opioid based pain medications due their potential addictive risks.
This study compares two groups of patients whom will have Roux en Y Gastric Bypass Surgery at UC Davis Medical Center, the control group will receive standard of care pain control medications (including opioid based medications) compared to the research arm, this group will receive Gabapentinin and Tylenol for pain control after surgery with rescue pain medications available if needed.
Post surgery both groups will be managed by the Bariatric Surgery Team and will be contacted periodically as part of the standard of care to monitor pain control and usage of any rescue medications (if needed).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- Women who undergo index weight loss procedures at UC Davis Medical Center
- Women with a BMI =>30
- Age from 35-65
- American Society of Anesthesiology (ASA) score of 3 or less
- No previous history of prior abdominal/foregut surgery
Exclusion Criteria
- Not having an index weight los surgery for obesity
- Do not meet the NIH Standards for weight loss surgery
- Additional planned or unplanned procedures during the index surgical procedure such as Cholecystectomy or extensive lysis of adhesions (>30 minutes)
- BMI < 30
- Men
- Women considering or currently planning on gender altering/modification
- ASA score of 4 or higher
- Patients less than 35 years of age or older than 65 years of age at the time of surgical consent
- A history of open abdominal surgery including umbilical, ventral, or splengalic hernia repair with or without mesh implantation, transplant or vascular surgery or any foregut procedures including hiatal hernia repair or anti-reflux surgery
- Arthritis, Fibromyalgia, chronic pain syndrome
- Other conditions requiring daily use of oral pain medications
- Prisoners
- Allergy to Gabapentin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Flexeril Oral Product The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Dilaudid Injectable Product The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Hycet 7.5Mg-325Mg/15Ml Solution The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Zofran Injection The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Scopolamine patch The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Marcaine Injectable Product The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Multi-Modal Hycet 7.5Mg-325Mg/15Ml Solution Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Flexeril Oral Product Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Dilaudid Injectable Product Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Marcaine Injectable Product Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Scopolamine patch Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Zofran Injection Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Tylenol Suspension Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Standard of Care Oxycodone Hydrochloride The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Standard of Care Ativan The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications. Multi-Modal Neurontin Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Oxycodone Hydrochloride Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control. Multi-Modal Ativan Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
- Primary Outcome Measures
Name Time Method Change In Post Operative Pain Intensity 3 Days and 14 Days Post Surgery Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain
Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery 3 Days and 14 Days Post Surgery OME Table is used to measure opioid use post surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC Davis Health
🇺🇸Sacramento, California, United States