Postoperative PainPhase 3NCT04084548
Perioperative Lidocaine and Ketamine in Abdominal Surgery
A Phase 3 study testing Lidocaine and ketamine, Lidocaine and Ketamine in people with Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Lidocaine and ketamine, Lidocaine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 to 80 years old
- Elective inpatient open or laparoscopic abdominal surgery
- General anesthesia lasting 2 hours or longer.
Who cannot join
- 1. Planned postoperative mechanical ventilation
- 2. Planned regional anesthesia/analgesia
- 3. Perioperative gabapentin, magnesium, or nitrous oxide use
- 4. Pregnancy or breastfeeding
- 5. Morbid obesity (BMI ≥ 35 kg/m2)
- 6. American Society of Anesthesiologists (ASA) physical status IV-V
Show all 13Show fewer
- 7. Allergy to study medications
- 8. Contraindication to lidocaine (severe cardiac arrhythmia)
- 9. Contraindication to ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of monoamine oxidase inhibitors)
- 10. Chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for > 3 months)
- 11. Significant preoperative hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels > 5 times normal) or planned liver transplantation
- 12. Preoperative cardiac failure (left ventricular ejection fraction ≤ 40%)
- 13. Unable to communicate or comprehend study instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine and Ketamine in Abdominal Surgery
The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery.
Read the detailed description
The investigators propose a prospective, randomized, double-blind, placebo-controlled clinical trial (RCT) with a factorial design. Adults 18 to 80 years old having elective inpatient open or laparoscopic abdominal surgery with general anesthesia lasting 2 hours or longer will be included in this study.
- Conditions
- Postoperative Pain
- Keywords
- Multimodal analgesia, Lidocaine, Ketamine, Abdominal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine and ketamineDrug
Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
LidocaineDrug
Perioperative lidocaine infusion (1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)
KetamineDrug
Perioperative ketamine infusion (0.5 mg/kg bolus followed by an infusion of 0.3 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)
PlaceboDrug
Perioperative placebo infusion (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine and placebo | Experimental | Lidocaine and placebo Receives: Drug: Lidocaine |
| Ketamine and placebo | Experimental | Ketamine and placebo Receives: Drug: Ketamine |
| Lidocaine and ketamine | Experimental | Lidocaine and ketamine Receives: Drug: Lidocaine and ketamine |
| Placebo and placebo | Placebo comparator | Placebo and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Measured: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Total opioid consumption
Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Measured: First postoperative 48 hours
Secondary outcomes (2)
Overall benefit of analgesia score (OBAS)
Measures 7 different items, i.e. current pain, vomiting, itching, sweating, freezing, dizziness, and patient satisfaction related to pain management. Each item is scored from 0 to 4, with the total OBAS score ranging from 0 to 28. The lower the total OBAS score, the higher the benefit of analgesia.
Measured: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Quality of recovery (QoR-15) score
Measures 15 different items, i.e. ability to breathe easily, enjoy food, feel rested, have a good sleep, look after personal toilet and hygiene unaided, communicate with family or friends, getting support from hospital doctors and nurses, return to work or usual home activities, feel comfortable and in control, have a feeling of general well-being, as well as the presence of moderate pain, severe pain, nausea or vomiting, feeling worried or anxious, and feeling sad or depressed. Each item is scored from 0 to 10, with a total QoR-15 score ranging from 0 to 150. The higher the QoR-15 score, the better the quality of recovery in the postoperative period.
Measured: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Oct 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Minear, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084548
- Sponsor's protocol ID
- FLA 18-088
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grady MV, Mascha E, Sessler DI, Kurz A. The effect of perioperative intravenous lidocaine and ketamine on recovery after abdominal hysterectomy. Anesth Analg. 2012 Nov;115(5):1078-84. doi: 10.1213/ANE.0b013e3182662e01. Epub 2012 Sep 25.
PubMed 23011561Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
PubMed 29864216Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
PubMed 15621365Ye F, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9147. doi: 10.1097/MD.0000000000009147.
PubMed 29390443Zhao JB, Li YL, Wang YM, Teng JL, Xia DY, Zhao JS, Li FL. Intravenous lidocaine infusion for pain control after laparoscopic cholecystectomy: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(5):e9771. doi: 10.1097/MD.0000000000009771.
PubMed 29384867Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
PubMed 23044681
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine and Ketamine in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04084548
- Acronym / sponsor ID
- FLA 18-088
- Conditions
- Postoperative Pain
- Keywords
- Multimodal analgesia, Lidocaine, Ketamine, Abdominal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery.
Detailed description
The investigators propose a prospective, randomized, double-blind, placebo-controlled clinical trial (RCT) with a factorial design. Adults 18 to 80 years old having elective inpatient open or laparoscopic abdominal surgery with general anesthesia lasting 2 hours or longer will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine and placebo | Experimental | Drug: LidocaineLidocaine and placebo |
| Ketamine and placebo | Experimental | Drug: KetamineKetamine and placebo |
| Lidocaine and ketamine | Experimental | Drug: Lidocaine and ketamineLidocaine and ketamine |
| Placebo and placebo | Placebo comparator | Drug: PlaceboPlacebo and placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 to 80 years old
- Elective inpatient open or laparoscopic abdominal surgery
- General anesthesia lasting 2 hours or longer.
Key exclusion criteria (13 listed)
- 1. Planned postoperative mechanical ventilation
- 2. Planned regional anesthesia/analgesia
- 3. Perioperative gabapentin, magnesium, or nitrous oxide use
- 4. Pregnancy or breastfeeding
- 5. Morbid obesity (BMI ≥ 35 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine and ketaminePerioperative lidocaine and ketamine infusion (see below for dosages and timings) | Drug | Lidocaine and ketamine |
| LidocainePerioperative lidocaine infusion (1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU) | Drug | Lidocaine and placebo |
| KetaminePerioperative ketamine infusion (0.5 mg/kg bolus followed by an infusion of 0.3 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU) | Drug | Ketamine and placebo |
| PlaceboPerioperative placebo infusion (normal saline) | Drug | Placebo and placebo |
Primary outcome
Pain scores
Time frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Total opioid consumption
Time frame: First postoperative 48 hours
Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
2 secondary outcomes
Overall benefit of analgesia score (OBAS)
Time frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Quality of recovery (QoR-15) score
Time frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 23011561Grady MV, Mascha E, Sessler DI, Kurz A. The effect of perioperative intravenous lidocaine and ketamine on recovery after abdominal hysterectomy. Anesth Analg. 2012 Nov;115(5):1078-84. doi: 10.1213/ANE.0b013e3182662e01. Epub 2012 Sep 25.
- Background: PubMed 29864216Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
- Background: PubMed 15621365Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
- Background: PubMed 29390443Ye F, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9147. doi: 10.1097/MD.0000000000009147.
- Background: PubMed 29384867Zhao JB, Li YL, Wang YM, Teng JL, Xia DY, Zhao JS, Li FL. Intravenous lidocaine infusion for pain control after laparoscopic cholecystectomy: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(5):e9771. doi: 10.1097/MD.0000000000009771.
- Background: PubMed 23044681Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Minear, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and ketamine, Lidocaine and Ketamine in people with Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084548, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.