Obesity, MorbidPhase 4NCT04240626
Multimodal Analgesia Effect on Post Surgical Patient
A Phase 4 study testing Neurontin, Dilaudid Injectable Product and Marcaine Injectable Product in people with Obesity, Morbid and Surgery, run by University of California, Davis at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Obesity, Morbid, Surgery, Bariatric Surgery Candidate
- What is being tested?
- Neurontin, Dilaudid Injectable Product and Marcaine Injectable Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 24 Jun 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Conditions
- Obesity, Morbid, Surgery, Bariatric Surgery Candidate
- Being tested
- Neurontin, Dilaudid Injectable Product, Marcaine Injectable Product, Oxycodone Hydrochloride, Hycet 7.5Mg-325Mg/15Ml Solution
- Keywords
- Bariatric Surgery,, Pain Control, Gabapentinin
- Medical subject headings
- Obesity, Morbid, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurontinDrug
Also called Gabapentin
600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours
Dilaudid Injectable ProductDrug
Also called Hydromorphone
.5-1 mg IV Q3 hours and IV Tylenol 1000mg every 6 hours post surgery transitioning to oral pain control medications (Hycet 7.5/325mg/5 ml, 5-10 ml every 4 hours
Marcaine Injectable ProductDrug
0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
Oxycodone HydrochlorideDrug
1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
Hycet 7.5Mg-325Mg/15Ml SolutionDrug
Also called Hydrocodone
Dosage: 10-15ml q4h prn for pain control
Zofran InjectionDrug
Also called Odanesetron
4 mg IV for nausea control while inpatient, prn
Scopolamine patchDrug
Also called Scopolamine
Topical application patch for nausea control, used with/without Ativan.
AtivanDrug
0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
Flexeril Oral ProductDrug
Also called Cyclobenziparin
5 mg orally q8h prn for muscle spasms.
Tylenol SuspensionDrug
Also called Acetaminophen
1000 mg q6h PRN for pain control.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | 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. Receives: Drug: Dilaudid Injectable Product; Drug: Marcaine Injectable Product; Drug: Oxycodone Hydrochloride; Drug: Hycet 7.5Mg-325Mg/15Ml Solution; Drug: Zofran Injection; Drug: Scopolamine patch; Drug: Ativan; Drug: Flexeril Oral Product |
| Multi-Modal | Experimental | 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. Receives: Drug: Neurontin; Drug: Dilaudid Injectable Product; Drug: Marcaine Injectable Product; Drug: Oxycodone Hydrochloride; Drug: Hycet 7.5Mg-325Mg/15Ml Solution; Drug: Zofran Injection; Drug: Scopolamine patch; Drug: Ativan; Drug: Flexeril Oral Product; Drug: Tylenol Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Post Operative Pain Intensity
Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain
Measured: 3 Days and 14 Days Post Surgery
Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery
OME Table is used to measure opioid use post surgery
Measured: 3 Days and 14 Days Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Jan 2021
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive Gabapentin and Ofirmev post surgery (dosage based on patients pre-operative weight) with on-call medications as needed including narcotic analgesia for breakthrough pain control
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R Ali, MD, FACS, Principal investigator, Professor of SurgeryBarbara Jachniewicz, MSN, CRNFA,, Principal investigator, Nurse Practitioner, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240626
- Sponsor's protocol ID
- 1452523
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No