Postoperative PainPhase 4NCT02085577
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
A Phase 4 study testing (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml, Isotonic sodium chloride 0.9 percent and Paracetamol 1 g in people with Postoperative Pain and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Chronic Pain, Analgesics
- What is being tested?
- (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml, Isotonic sodium chloride 0.9 percent and Paracetamol 1 g
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to 1 Nov 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lumbar spinal fusion surgery in general anesthesia.
- Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidone, oxycodone, fentanyl, tramadol and/or buprenorphine).
- Back pain for a minimum of 3 months preoperatively.
- Age > 18 years and < 85 years.
- ASA 1-3.
- BMI > 18 and < 40.
- Fertile women need to have a negative urine HCG pregnancy test.
- Patients who have given their written informed consent to participate in the study after understanding the content and limitations of the study
Who cannot join
- Participation in another concomitant drug trial.
- Patients who do not understand or speak Danish.
- Allergy to the drugs used in the trial.
- Abuse of drugs - as assessed by the investigator.
- Daily methadone use.
- Increased intraocular pressure - assessed from the patients chart.
- Uncontrolled hypertension - assessed from the patients chart.
- Previous and current psychotic episodes - assessed from the patients chart
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology, Glostrup Hospital
Glostrup Municipality, 2600
About this study
Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.
Read the detailed description
Opioid-dependent patients can develop hyperalgesia and often have a high opioid consumption postoperatively due to opioid tolerance. Intraoperative ketamine in subanesthetic doses can possibly reduce hyperalgesia and reduce opioid-tolerance in these patients. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nerve system. It can be used for general anesthesia but the drug also has other properties including lowering of central excitability and reducing postoperative opioid tolerance by modeling the opioid receptors. Further more it can possibly reduce chronic pain by blocking wind-up effect when blocking the NMDA receptors.
Our purpose is to investigate the effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients. Our hypothesis is that ketamine can reduce opioid consumption and reduce postoperative pain and side effects compared to placebo.
- Conditions
- Postoperative Pain, Chronic Pain, Analgesics
- Being tested
- (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml, Isotonic sodium chloride 0.9 percent, Paracetamol 1 g, Morphine Sulphate 1 mg/ml, Ondansetron 2 mg/ml
- Keywords
- Morphine consumption, Postoperative pain, Ketamine, Side effects, Spine surgery, Chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(S)-(+)-Ketamine Hydrochloride Solution 25 mg/mlDrug
Also called Ketamine
Ketamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed.
Isotonic sodium chloride 0.9 percentDrug
Also called Isotonic saline
Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed.
Paracetamol 1 gDrug
Also called Paracetamol
Paracetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours.
Morphine Sulphate 1 mg/mlDrug
Also called Morphine
Morphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively
Morphine Sulphate 1 mg/mlDrug
Also called Morphine
Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.
Ondansetron 2 mg/mlDrug
Also called Zofran
Ondansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed
Usual daily opioidsDrug
Also called Morphine
The patients usual daily opioid consumption are administered during the study period
Morphine Sulphate 1 mg/mlDrug
Also called Morphine
Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 minutes before expected awakening.
Sufentanil 5 microgram/mlDrug
Also called Sufentanil
Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | * (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/h terminated at last suture to the skin.
* Morphine. Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 min before expected awakening.
* Escape sufentanil. Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.
* Morphine. PCA-morphine, bolus 2.5 mg, lock-out-time 5 min. Concentration : Morphine sulphate 1 mg/ml.
* Escape morphine. Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.
* Ondansetron 2 mg/ml, 4 mg iv in case of moderate to severe nausea, supplemented by 1 mg iv if needed
* Paracetamol 1 g orally 1 h preoperatively and every 6 h after extubation time during the first 24 h.
* The patients usual daily opioids Receives: Drug: (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml; Drug: Paracetamol 1 g; Drug: Morphine Sulphate 1 mg/ml; Drug: Ondansetron 2 mg/ml; Drug: Usual daily opioids; Drug: Sufentanil 5 microgram/ml |
| Placebo | Placebo comparator | * Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/h terminated at last suture to the skin.
* Morphine. Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 min before expected awakening.
* Escape sufentanil. Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.
* Morphine. PCA-morphine, bolus 2.5 mg, lock-out-time 5 min. Concentration : Morphine sulphate 1 mg/ml.
* Escape morphine. Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.
* Ondansetron 2 mg/ml, 4 mg iv in case of moderate to severe nausea, supplemented by 1 mg iv if needed
* Paracetamol 1 g orally 1 h preoperatively and every 6 h after extubation time during the first 24 h.
* The patients usual daily opioids Receives: Drug: Isotonic sodium chloride 0.9 percent; Drug: Paracetamol 1 g; Drug: Morphine Sulphate 1 mg/ml; Drug: Ondansetron 2 mg/ml; Drug: Usual daily opioids; Drug: Sufentanil 5 microgram/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total intravenous morphine consumption, other than the patients usual opioid use, 0- 24 hours postoperatively, administered as patient-controlled analgesia ((PCA), bolus 2.5 mg, lockout 5 minutes)
Measured: 0-24 hours postoperatively
Secondary outcomes (9)
Pain during mobilization
Pain score during active mobilization, measured on a visual analogue scale (VAS) (0-100 mm), defined as a standardized movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. The endpoint, VAS-mobilization, will be calculated as area under the curve (AUC) (2-24h) from these measurements.
Measured: 2, 6, 12, 18 and 24 hours postoperatively
Pain at rest
Pain score at rest, measured on a visual analogue scale (VAS) (0-100 mm), at 2, 6, 12, 18 and 24 hours postoperatively. The endpoint, VAS-rest, will be calculated as area under the curve (AUC) (2-24h) from these measurements.
Measured: 2, 6, 12, 18 & 24 hours postoperatively
Nausea
Level of nausea (none, mild, moderate, severe) (0-24h), measured at 2, 6, 12, 18 and 24 hours postoperatively.
Measured: 2, 6, 12, 18 & 24 hours postoperatively
Vomiting
Number of vomiting episodes (0-24 hours), registered in the periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively.
Measured: 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively
Ondansetron
Consumption of ondansetron (mg) during 0-24 hours postoperatively.
Measured: 0-24 hours postoperatively
Sedation
Level of sedation (none, mild, moderate, severe) (0-24 h) registered at time 2, 6, 12, 18 and 24 hours postoperatively.
Measured: 2, 6, 12, 18 & 24 hours postoperatively
Hallucinations and nightmares
Episodes of hallucinations and nightmares (yes/no) in the period 0-24 hours postoperatively.
Measured: 0-24 hours postoperatively
Chronic pain
Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 6 months postoperatively.
Measured: 6 months postoperatively
Chronic pain
Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 12 months postoperatively.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completion1 Nov 2016
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Rikke Vibeke Nielsen, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rikke V Nielsen, MD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085577
- Sponsor's protocol ID
- SM3-RS-2014
- Other IDs
- 2014-000839-16, 2014
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- 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 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
- ClinicalTrials.gov ID
- NCT02085577
- Acronym / sponsor ID
- SM3-RS-2014
- Conditions
- Postoperative Pain, Chronic Pain, Analgesics
- Keywords
- Morphine consumption, Postoperative pain, Ketamine, Side effects, Spine surgery, Chronic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 13 Mar 2014 (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.
Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.
Detailed description
Opioid-dependent patients can develop hyperalgesia and often have a high opioid consumption postoperatively due to opioid tolerance. Intraoperative ketamine in subanesthetic doses can possibly reduce hyperalgesia and reduce opioid-tolerance in these patients. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nerve system. It can be used for general anesthesia but the drug also has other properties including lowering of central excitability and reducing postoperative opioid tolerance by modeling the opioid receptors. Further more it can possibly reduce chronic pain by blocking wind-up effect when blocking the NMDA receptors.
Our purpose is to investigate the effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients. Our hypothesis is that ketamine can reduce opioid consumption and reduce postoperative pain and side effects compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml, Drug: Paracetamol 1 g, Drug: Morphine Sulphate 1 mg/ml, Drug: Ondansetron 2 mg/ml, Drug: Usual daily opioids, Drug: Sufentanil 5 microgram/ml* (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/h terminated at last suture to the skin. * Morphine. Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 min before expected awakening. * Escape sufentanil. Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening. * Morphine. PCA-morphine, bolus 2.5 mg, lock-out-time 5 min. Concentration : Morphine sulphate 1 mg/ml. * Escape morphine. Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively. * Ondansetron 2 mg/ml, 4 mg iv in case of moderate to severe nausea, supplemented by 1 mg iv if needed * Paracetamol 1 g orally 1 h preoperatively and every 6 h after extubation time during the first 24 h. * The patients usual daily opioids |
| Placebo | Placebo comparator | Drug: Isotonic sodium chloride 0.9 percent, Drug: Paracetamol 1 g, Drug: Morphine Sulphate 1 mg/ml, Drug: Ondansetron 2 mg/ml, Drug: Usual daily opioids, Drug: Sufentanil 5 microgram/ml* Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/h terminated at last suture to the skin. * Morphine. Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 min before expected awakening. * Escape sufentanil. Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening. * Morphine. PCA-morphine, bolus 2.5 mg, lock-out-time 5 min. Concentration : Morphine sulphate 1 mg/ml. * Escape morphine. Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively. * Ondansetron 2 mg/ml, 4 mg iv in case of moderate to severe nausea, supplemented by 1 mg iv if needed * Paracetamol 1 g orally 1 h preoperatively and every 6 h after extubation time during the first 24 h. * The patients usual daily opioids |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing lumbar spinal fusion surgery in general anesthesia.
- Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidone, oxycodone, fentanyl, tramadol and/or buprenorphine).
- Back pain for a minimum of 3 months preoperatively.
- Age > 18 years and < 85 years.
- ASA 1-3.
Key exclusion criteria (8 listed)
- Participation in another concomitant drug trial.
- Patients who do not understand or speak Danish.
- Allergy to the drugs used in the trial.
- Abuse of drugs - as assessed by the investigator.
- Daily methadone use.
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 |
|---|---|---|
| (S)-(+)-Ketamine Hydrochloride Solution 25 mg/mlAlso: KetamineKetamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed. | Drug | Ketamine |
| Isotonic sodium chloride 0.9 percentAlso: Isotonic salineIsotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed. | Drug | Placebo |
| Paracetamol 1 gAlso: ParacetamolParacetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours. | Drug | Ketamine, Placebo |
| Morphine Sulphate 1 mg/mlAlso: MorphineMorphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively | Drug | Ketamine, Placebo |
| Morphine Sulphate 1 mg/mlAlso: MorphineMorphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively. | Drug | Ketamine, Placebo |
| Ondansetron 2 mg/mlAlso: ZofranOndansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed | Drug | Ketamine, Placebo |
| Usual daily opioidsAlso: MorphineThe patients usual daily opioid consumption are administered during the study period | Drug | Ketamine, Placebo |
| Morphine Sulphate 1 mg/mlAlso: MorphineMorphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 minutes before expected awakening. | Drug | Ketamine, Placebo |
| Sufentanil 5 microgram/mlAlso: SufentanilSufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening. | Drug | Ketamine, Placebo |
Primary outcome
Morphine consumption
Time frame: 0-24 hours postoperatively
Total intravenous morphine consumption, other than the patients usual opioid use, 0- 24 hours postoperatively, administered as patient-controlled analgesia ((PCA), bolus 2.5 mg, lockout 5 minutes)
9 secondary outcomes
Pain during mobilization
Time frame: 2, 6, 12, 18 and 24 hours postoperatively
Pain at rest
Time frame: 2, 6, 12, 18 & 24 hours postoperatively
Nausea
Time frame: 2, 6, 12, 18 & 24 hours postoperatively
Vomiting
Time frame: 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively
Ondansetron
Time frame: 0-24 hours postoperatively
Sedation
Time frame: 2, 6, 12, 18 & 24 hours postoperatively
Hallucinations and nightmares
Time frame: 0-24 hours postoperatively
Chronic pain
Time frame: 6 months postoperatively
Chronic pain
Time frame: 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- 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.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Rikke V Nielsen, MD principal investigator
Glostrup University Hospital, Copenhagen
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 (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml, Isotonic sodium chloride 0.9 percent and Paracetamol 1 g in people with Postoperative Pain and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 8 inclusion and 8 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 28 Apr 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 0-24 hours postoperatively). 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 NCT02085577, 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 28 Apr 2017.