Chronic Low Back PainNCT00899600
Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain
A study testing Ketamine and Normal saline in people with Chronic Low Back Pain, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Ketamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laminectomy procedures.
- History of chronic back pain.
- Daily opioid use.
- Capable of providing informed consent.
Who cannot join
- Intolerance/allergy to ketamine.
- Intolerance/true allergy to morphine.
- Elevated intra-ocular pressure.
- Uncontrolled hypertension.
- Elevated intra-cranial pressure.
- Any history of a psychosis.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Intra-operative Ketamine Infusions in Patients With Chronic Lower Back Discomfort Undergoing Laminectomies.
Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions (3).
Spine surgery provides a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid consumption in patients with chronic pain. The goal of this double blinded, prospective, randomized placebo controlled trial is to quantify the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to postoperative opioid use.
Read the detailed description
Noxious stimuli occurring intra-operatively and post-operatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors that have been implicated in the prolongation of painful states in animal models. The N-methyl-d-aspartate (NMDA) receptor is one such excitatory amino acid receptor (1, 2).
The underlying mechanism of central sensitization is thought to involve c-fiber associated injury occurring with incision. Crile and Wall brought about the concept that attenuation of central sensitization could be accomplished via the provision of analgesic interventions (opioids, local anesthesia) prior to the noxious insult. They termed the central sensitization attenuation preemptive analgesia. The concept of preemptive analgesia was later expanded to implicate both pre and post-incisional noxious stimuli as part of this process, resulting in studies designed to provide interventions throughout the surgical intervention (peri-procedural) (3). Reduction in analgesic requirements or pain scores for more than five half-lives (1st order kinetics) following the provision of the intervening analgesic agent peri-procedurally is now known as preventative analgesia. The term preemptive analgesia is now reserved for interventions that occur only before the noxious stimuli.
Multiple studies have investigated the concepts of preemptive analgesia and preventative analgesia by providing a variety of analgesic interventions at various times throughout the surgical insult in addition to more conventional means of anesthesia provision, including opioids, Non-Steroidal Anti-Inflammatory Drugs (NSAID)s, Cyclooxygenase-II (COX-2) inhibitors, alpha-2 agonists, and ketamine (4, 5, 6). Preemptive and preventative analgesia using a variety of pharmacological agents with at least partially known mechanisms of actions has provided some insight into potential mechanisms of central sensitization.
Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions with variable routes of administration. It has also been shown to be effective in the presence and absence of opioids, suggesting that it has more than one mechanism of action in preemptive and preventative analgesia, including but not limited to decreasing central excitability, decreasing acute post-operative opioid tolerance, and a possible modulation of opioid receptors (7). Ketamine is a common anesthetic agent and has been in use since the Vietnam War. Clinically, ketamine provides pain relief with minimal respiratory depression, and at higher doses (1-2mg/kg) can induce general anesthesia while maintaining blood pressure and cardiac output.
Recently, a qualitative systematic review of the role of NMDA receptor antagonists was completed. Twenty-four studies investigating the role of ketamine met the inclusion criteria of the study, 58% of which demonstrated a preemptive or preventative analgesic effect. Patients underwent a variety of surgical procedures, both ambulatory and inpatient, and there was no obvious effect of either surgical type or dose of ketamine (range 0.15 to 1mg/kg) on the success of preventative intervention. However, the authors were unable to quantify the degree of reduction in primary end-points (opioid consumption, pain scores, both) due to variability in recording of such data. In addition, most inpatient studies were limited to abdominal procedures while the outpatient studies investigated mainly knee arthroscopies, providing no insight into the degree of impact of NMDA receptor antagonism in the setting of high pre-operative opioid tolerance combined with surgical procedures known to be associated with an invariably high degree of post-operative pain. Of note, only 1/24 studies documented a significant difference in side effects related to ketamine provision in patients who had received 20mg of epidural ketamine (7).
Laminectomy procedures provide a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of acute post-operative pain scores and opioid consumption in a patient population with opioid dependence and a high degree of post-operative and intra-operative noxious stimuli. The goal of this double blinded, randomized placebo controlled trial will be to test for the presence of, and quantify, the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to post-operative opioid use including but not limited to respiratory depression, constipation, and delirium.
- Conditions
- Chronic Low Back Pain
- Being tested
- Ketamine, Normal saline
- Keywords
- chronic pain, back surgery, opioid dependent, NMDA receptor antagonism, Ketamine, Central sensitization
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure
Normal salineOther
Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Not described Receives: Other: Normal saline |
| Ketamine | Experimental | Not described Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption in the First 48 Hours After Surgery
Total morphine(mg)consumed at 48 hours.
Measured: 48 hours
Secondary outcomes (4)
Hospital Duration
Measured: Discharge from hospital, approximately 2 days after surgery
Hemodynamic Changes - Heart Rate
Hemodynamic change (Heart Rate) from baseline in the intraoperative and 48-h postoperative periods
Measured: Baseline, Inoperative (approximately) 48 hours
Hemodynamic Changes - Blood Pressure
Hemodynamic change (Blood Pressure) from baseline in the intraoperative and 48-h postoperative periods
Measured: Baseline, Inoperative (approximately) 48 hours
Percentage of Participants With Complications/Adverse Events
Adverse events
Measured: 48 hours and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Clark, MD, Principal investigator, DHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899600
- Sponsor's protocol ID
- 100674
- Status last verified
- Sep 2018
- First submitted
- 8 May 2009
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
1. Wall PD. The prevention of postoperative pain. Pain 1988; 33: 289-90. 2. Katz J. George Washington Crile, anoci-association, and preemptive analgesia. Pain 1993;53: 243-5. 3. McQual HJ. Pre-emptive analgesia. Br J Anaesth 1992;69: 1-3. 4. Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology 2002;96: 725-41. 5. Katz J. Pre-emptive analgesia: evidence, current status and future directions. Eur J Anaesthesiol Suppl 995;10:8-13. 6. Katz J, McCartney CJ. Update on pre-emptive analgesia. Curr Opin Anesthesiol 2002; 15: 435-41. 7. McCartney et al. A qualitative systematic review of the role of N-Methyl-D-Aspartate receptor antagonists in preventative analgesia. Anesth Analg 2004; 98: 1385-1400. 8. Wu CT, Yeh CC, Yu JC, et al. Pre-incisional epidural ketamine, morphine and bupivacaine combined with epidural and general anesthesia provides pre-emptive analgesia for upper abdominal surgery. Acta Anaesthesiol Scand 2000;44: 63-8.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Ketamine Infusions in Patients With Chronic Lower Back Discomfort Undergoing Laminectomies.
- ClinicalTrials.gov ID
- NCT00899600
- Acronym / sponsor ID
- 100674
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic pain, back surgery, opioid dependent, NMDA receptor antagonism, Ketamine, Central sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 11 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions (3).
Spine surgery provides a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid consumption in patients with chronic pain. The goal of this double blinded, prospective, randomized placebo controlled trial is to quantify the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to postoperative opioid use.
Detailed description
Noxious stimuli occurring intra-operatively and post-operatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors that have been implicated in the prolongation of painful states in animal models. The N-methyl-d-aspartate (NMDA) receptor is one such excitatory amino acid receptor (1, 2).
The underlying mechanism of central sensitization is thought to involve c-fiber associated injury occurring with incision. Crile and Wall brought about the concept that attenuation of central sensitization could be accomplished via the provision of analgesic interventions (opioids, local anesthesia) prior to the noxious insult. They termed the central sensitization attenuation preemptive analgesia. The concept of preemptive analgesia was later expanded to implicate both pre and post-incisional noxious stimuli as part of this process, resulting in studies designed to provide interventions throughout the surgical intervention (peri-procedural) (3). Reduction in analgesic requirements or pain scores for more than five half-lives (1st order kinetics) following the provision of the intervening analgesic agent peri-procedurally is now known as preventative analgesia. The term preemptive analgesia is now reserved for interventions that occur only before the noxious stimuli.
Multiple studies have investigated the concepts of preemptive analgesia and preventative analgesia by providing a variety of analgesic interventions at various times throughout the surgical insult in addition to more conventional means of anesthesia provision, including opioids, Non-Steroidal Anti-Inflammatory Drugs (NSAID)s, Cyclooxygenase-II (COX-2) inhibitors, alpha-2 agonists, and ketamine (4, 5, 6). Preemptive and preventative analgesia using a variety of pharmacological agents with at least partially known mechanisms of actions has provided some insight into potential mechanisms of central sensitization.
Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions with variable routes of administration. It has also been shown to be effective in the presence and absence of opioids, suggesting that it has more than one mechanism of action in preemptive and preventative analgesia, including but not limited to decreasing central excitability, decreasing acute post-operative opioid tolerance, and a possible modulation of opioid receptors (7). Ketamine is a common anesthetic agent and has been in use since the Vietnam War. Clinically, ketamine provides pain relief with minimal respiratory depression, and at higher doses (1-2mg/kg) can induce general anesthesia while maintaining blood pressure and cardiac output.
Recently, a qualitative systematic review of the role of NMDA receptor antagonists was completed. Twenty-four studies investigating the role of ketamine met the inclusion criteria of the study, 58% of which demonstrated a preemptive or preventative analgesic effect. Patients underwent a variety of surgical procedures, both ambulatory and inpatient, and there was no obvious effect of either surgical type or dose of ketamine (range 0.15 to 1mg/kg) on the success of preventative intervention. However, the authors were unable to quantify the degree of reduction in primary end-points (opioid consumption, pain scores, both) due to variability in recording of such data. In addition, most inpatient studies were limited to abdominal procedures while the outpatient studies investigated mainly knee arthroscopies, providing no insight into the degree of impact of NMDA receptor antagonism in the setting of high pre-operative opioid tolerance combined with surgical procedures known to be associated with an invariably high degree of post-operative pain. Of note, only 1/24 studies documented a significant difference in side effects related to ketamine provision in patients who had received 20mg of epidural ketamine (7).
Laminectomy procedures provide a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of acute post-operative pain scores and opioid consumption in a patient population with opioid dependence and a high degree of post-operative and intra-operative noxious stimuli. The goal of this double blinded, randomized placebo controlled trial will be to test for the presence of, and quantify, the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to post-operative opioid use including but not limited to respiratory depression, constipation, and delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Other: Normal saline |
| Ketamine | Experimental | Drug: Ketamine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laminectomy procedures.
- History of chronic back pain.
- Daily opioid use.
- Capable of providing informed consent.
Key exclusion criteria (7 listed)
- Intolerance/allergy to ketamine.
- Intolerance/true allergy to morphine.
- Elevated intra-ocular pressure.
- Uncontrolled hypertension.
- Elevated intra-cranial pressure.
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 |
|---|---|---|
| KetaminePeripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure | Drug | Ketamine |
| Normal salineNormal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg). | Other | Normal saline |
Primary outcome
Morphine Consumption in the First 48 Hours After Surgery
Time frame: 48 hours
Total morphine(mg)consumed at 48 hours.
4 secondary outcomes
Hospital Duration
Time frame: Discharge from hospital, approximately 2 days after surgery
Hemodynamic Changes - Heart Rate
Time frame: Baseline, Inoperative (approximately) 48 hours
Hemodynamic Changes - Blood Pressure
Time frame: Baseline, Inoperative (approximately) 48 hours
Percentage of Participants With Complications/Adverse Events
Time frame: 48 hours and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1. Wall PD. The prevention of postoperative pain. Pain 1988; 33: 289-90. 2. Katz J. George Washington Crile, anoci-association, and preemptive analgesia. Pain 1993;53: 243-5. 3. McQual HJ. Pre-emptive analgesia. Br J Anaesth 1992;69: 1-3. 4. Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology 2002;96: 725-41. 5. Katz J. Pre-emptive analgesia: evidence, current status and future directions. Eur J Anaesthesiol Suppl 995;10:8-13. 6. Katz J, McCartney CJ. Update on pre-emptive analgesia. Curr Opin Anesthesiol 2002; 15: 435-41. 7. McCartney et al. A qualitative systematic review of the role of N-Methyl-D-Aspartate receptor antagonists in preventative analgesia. Anesth Analg 2004; 98: 1385-1400. 8. Wu CT, Yeh CC, Yu JC, et al. Pre-incisional epidural ketamine, morphine and bupivacaine combined with epidural and general anesthesia provides pre-emptive analgesia for upper abdominal surgery. Acta Anaesthesiol Scand 2000;44: 63-8.
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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.
Jeffrey A Clark, MD principal investigator
DHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Normal saline in people with Chronic Low Back Pain, run by Dartmouth-Hitchcock Medical Center 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 4 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: finished, as of the sponsor's last update on 18 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morphine Consumption in the First 48 Hours After Surgery (time frame: 48 hours). 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 NCT00899600, 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 18 Oct 2018.