AnesthesiaPhase 4NCT02378740
Ketamine in Patients Undergoing Anterior Cervical Discectomy and Fusion
A Phase 4 study testing Saline and Ketamine in people with Anesthesia and Pain, run by Northwestern University at 1 site in United States.
Trial summary
Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to reduce pain while also decreasing intraoperative and postoperative opioid requirements when used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive antagonist of N-methyl-D-aspartate (NMDA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Pain, Surgery
- What is being tested?
- Saline and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years)
- Undergoing 1-3 level ACDF surgery
Who cannot join
- Patients under 18 years of age
- Non-English speaking patients
- Pregnancy
- Emergent procedures
- History of psychosis
- Uncontrolled hypertension
- Known or suspected allergy or intolerance to ketamine or its components.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Prospective, Block Randomized, Double-Blind Placebo-Controlled Trial of Ketamine in Patients Undergoing Anterior Cervical Discectomy and Fusion
Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to reduce pain while also decreasing intraoperative and postoperative opioid requirements when used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is believed to block the development of central sensitization and wind-up phenomenon,2,3 which may be helpful in preventing acute and chronic pain after repetitive insults. In a systematic review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was found to be a useful addition to standard postoperative pain management practice with opioids in 54% of studies.1 The studies that did not show a significant effect were in patient populations with low opioid requirements. Therefore, it has been suggested that future clinical trials be focused on patient populations with significant post-operative pain, such as spine surgery and major orthopedic surgery not amenable to regional analgesia, and postoperative pain in patients on chronic preoperative opioid therapy.1
There are few studies examining outcomes after ketamine in the perioperative period after spine surgery. Loftus et al randomized patients with a history of chronic preoperative opioid use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus placebo and found a 30% reduction in morphine consumption at 48 hours and an approximately 25% reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and at 6 weeks.4 Although this study provided evidence that there may be reduction in long-term postoperative pain, additional studies are needed to provide evidence that this effect is sustained beyond the 6-week period.
Read more
We are interested in examining ketamine more closely in spine surgery because this patient population experiences significant postoperative pain that may be difficult to control due to preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF patients specifically because it is a common spine procedure throughout the United States and the patients have significant opioid requirements postoperatively. In a study examining the effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and lumbar surgery, patients in the placebo group (and thus only receiving fentanyl PCA) reported mean VAS scores of 4-5 with movement while receiving opioids.5
Further, while previous studies have shown an opioid-sparing effect of ketamine as measured by opioid consumption and a decrease in pain as measured by VAS scores, no study to our knowledge has examined quality of recovery after intraoperative ketamine infusion. The Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of recovery after anesthesia based on forty questions in five dimensions,6 and this score has been shown to be a reliable and valid outcome for patients undergoing both spine and cranial surgery.7 QoR-40 is also of interest because it should be able to provide a global assessment of the possible benefit or harm of using ketamine in patients by simultaneously characterizing the detrimental side effects as well as the positive benefits of ketamine when used as an infusion at subanesthetic levels (studies thus far have shown that there are minimal side effects such as hallucinations).1,4
Significance:
Previous studies have shown an opioid-sparing effect of ketamine, however further research is warranted in patients whose pain may be difficult to control and whether this effect is sustained. ACDF patients experience significant pain post-operatively, and ketamine may improve their quality of recovery due to its opioid-sparing effects and prevention of chronic pain. Further, patient centered outcomes as measured by the QoR-40 have not been reported in the literature when ketamine, or other opioid sparing anesthetics, have been administered. This study will not only determine if the "moderate" dose of ketamine is beneficial or detrimental to the recovery of patients but also whether it can improve long term patient function, presumably by decreasing central pain sensitization. In addition, this study will set the stage for further RCT's examining other analgesic strategies in cervical spine surgery patients (i.e., intraoperative lidocaine infusions, volatile anesthetic vs. propofol as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The overall goal would be to develop a multi-faceted regimen that decreases the postoperative inpatient opioid requirements of these patients and may facilitate long term recovery.
The research questions:Does ketamine improve the quality of recovery at 24 hours after anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators hypothesize that ketamine will improve the quality of recovery after ACDF surgery
- Conditions
- Anesthesia, Pain, Surgery
- Being tested
- Saline, Ketamine
- Keywords
- Anesthesia, Cervical Fusion, Quality of Recovery, Ketamine Infusion
- Medical subject headings
- Pain, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
The study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine:
0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion
KetamineDrug
The study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine:
0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (.9 sterile normal saline) administered IV Receives: Drug: Saline |
| Ketamine | Active comparator | The study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine:
0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-40 score at 24 hours
Quality of recovery survey score completed by the patient
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: PI has left the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Moreland, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378740
- Sponsor's protocol ID
- STU00102734
- Status last verified
- Jun 2016
- First submitted
- 27 Feb 2015
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
PubMed 20693876
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Block Randomized, Double-Blind Placebo-Controlled Trial of Ketamine in Patients Undergoing Anterior Cervical Discectomy and Fusion
- ClinicalTrials.gov ID
- NCT02378740
- Acronym / sponsor ID
- STU00102734
- Conditions
- Anesthesia, Pain, Surgery
- Keywords
- Anesthesia, Cervical Fusion, Quality of Recovery, Ketamine Infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left the University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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.
Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to reduce pain while also decreasing intraoperative and postoperative opioid requirements when used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is believed to block the development of central sensitization and wind-up phenomenon,2,3 which may be helpful in preventing acute and chronic pain after repetitive insults. In a systematic review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was found to be a useful addition to standard postoperative pain management practice with opioids in 54% of studies.1 The studies that did not show a significant effect were in patient populations with low opioid requirements. Therefore, it has been suggested that future clinical trials be focused on patient populations with significant post-operative pain, such as spine surgery and major orthopedic surgery not amenable to regional analgesia, and postoperative pain in patients on chronic preoperative opioid therapy.1
There are few studies examining outcomes after ketamine in the perioperative period after spine surgery. Loftus et al randomized patients with a history of chronic preoperative opioid use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus placebo and found a 30% reduction in morphine consumption at 48 hours and an approximately 25% reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and at 6 weeks.4 Although this study provided evidence that there may be reduction in long-term postoperative pain, additional studies are needed to provide evidence that this effect is sustained beyond the 6-week period.
We are interested in examining ketamine more closely in spine surgery because this patient population experiences significant postoperative pain that may be difficult to control due to preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF patients specifically because it is a common spine procedure throughout the United States and the patients have significant opioid requirements postoperatively. In a study examining the effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and lumbar surgery, patients in the placebo group (and thus only receiving fentanyl PCA) reported mean VAS scores of 4-5 with movement while receiving opioids.5
Further, while previous studies have shown an opioid-sparing effect of ketamine as measured by opioid consumption and a decrease in pain as measured by VAS scores, no study to our knowledge has examined quality of recovery after intraoperative ketamine infusion. The Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of recovery after anesthesia based on forty questions in five dimensions,6 and this score has been shown to be a reliable and valid outcome for patients undergoing both spine and cranial surgery.7 QoR-40 is also of interest because it should be able to provide a global assessment of the possible benefit or harm of using ketamine in patients by simultaneously characterizing the detrimental side effects as well as the positive benefits of ketamine when used as an infusion at subanesthetic levels (studies thus far have shown that there are minimal side effects such as hallucinations).1,4
Significance:
Previous studies have shown an opioid-sparing effect of ketamine, however further research is warranted in patients whose pain may be difficult to control and whether this effect is sustained. ACDF patients experience significant pain post-operatively, and ketamine may improve their quality of recovery due to its opioid-sparing effects and prevention of chronic pain. Further, patient centered outcomes as measured by the QoR-40 have not been reported in the literature when ketamine, or other opioid sparing anesthetics, have been administered. This study will not only determine if the "moderate" dose of ketamine is beneficial or detrimental to the recovery of patients but also whether it can improve long term patient function, presumably by decreasing central pain sensitization. In addition, this study will set the stage for further RCT's examining other analgesic strategies in cervical spine surgery patients (i.e., intraoperative lidocaine infusions, volatile anesthetic vs. propofol as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The overall goal would be to develop a multi-faceted regimen that decreases the postoperative inpatient opioid requirements of these patients and may facilitate long term recovery.
The research questions:Does ketamine improve the quality of recovery at 24 hours after anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators hypothesize that ketamine will improve the quality of recovery after ACDF surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalinePlacebo (.9 sterile normal saline) administered IV |
| Ketamine | Active comparator | Drug: KetamineThe study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine: 0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years)
- Undergoing 1-3 level ACDF surgery
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Non-English speaking patients
- Pregnancy
- Emergent procedures
- History of psychosis
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 |
|---|---|---|
| SalineThe study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine: 0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion | Drug | Placebo |
| KetamineThe study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine: 0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion | Drug | Ketamine |
Primary outcome
Quality of Recovery-40 score at 24 hours
Time frame: 24 hours after surgery
Quality of recovery survey score completed by the patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Background: PubMed 20693876Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
- 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.
Natalie Moreland, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline and Ketamine in people with Anesthesia and Pain, run by Northwestern University 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Jun 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quality of Recovery-40 score at 24 hours (time frame: 24 hours after surgery). 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 NCT02378740, which also lists 1 linked publication.
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 15 Jun 2016.