PainPhase 4NCT01953978
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery
A Phase 4 study testing Dexamethasone, Morphine and Zofran in people with Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Dexamethasone, Morphine and Zofran
- 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
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Sep 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lumbar disc surgery in general anaesthesia.
- Patients who have given their written consent to participate and understand the contents of the protocol.
- ASA 1-3.
- BMI > 18 og < 40.
- Fertile women need a negative HCG urine test.
Who cannot join
- Patients who cannot cooperate to the study.
- Patients who do not speak and/or understand Danish.
- Fertile women with a positive HCG urine test.
- Allergy to the drugs used in the trial.
- Alcohol or medicine abuse, assessed by investigator.
- Patients who have had spine surgery before.
- Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
- Daily oral steroid treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
Read the detailed description
The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
- Conditions
- Pain
- Being tested
- Dexamethasone, Placebo, Morphine, Zofran, Paracetamol
- Keywords
- Pain, Analgesia, Postoperative, Dexamethasone, Spine surgery
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
PlaceboOther
Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
MorphineDrug
Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
ZofranDrug
Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
ParacetamolDrug
Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
IbuprofenDrug
Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | * Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
* Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
* Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
* Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. Receives: Drug: Dexamethasone; Drug: Morphine; Drug: Zofran; Drug: Paracetamol; Drug: Ibuprofen |
| Placebo | Placebo comparator | * Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
* Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
* Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
* Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. Receives: Other: Placebo; Drug: Morphine; Drug: Zofran; Drug: Paracetamol; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painscore during mobilization
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.
Measured: 2-24 hours after extubation time.
Secondary outcomes (8)
Painscore during rest
Painscore during rest (VAS scale) at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.
Measured: 2-24 hours after extubation time
Morphine consumption
Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).
Measured: 0-24 hours after extubation time.
Painscore during rest and mobilization
Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.
Measured: 48 hours after extubation time
Degree of nausea
Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time
Measured: 2, 4, 8, 12, 24 and 48 hours after extubation time
Incidence of vomiting
Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
Measured: 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
Zofran consumption
Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.
Measured: 0-24 and 24-48 hours after extubation time.
Degree of sedation
Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.
Measured: 2, 4, 8, 12, 24 and 48 hours after extubation time.
Quality of sleep
Quality of sleep 24 hours after extubation time.
Measured: 24 hours after extubation time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 160 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, Glostrup University Hospital, Copenhagen
- Investigators
- Rikke Soennichsen, MD, Principal investigator, Glostrup University HospitalJoergen B Dahl, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953978
- Sponsor's protocol ID
- SM-RS-2012
- Other IDs
- 2012-004181-18
- Status last verified
- Oct 2015
- First submitted
- 26 Sep 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z.
PubMed 27852230Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326.
PubMed 26270586
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
- ClinicalTrials.gov ID
- NCT01953978
- Acronym / sponsor ID
- SM-RS-2012
- Conditions
- Pain
- Keywords
- Pain, Analgesia, Postoperative, Dexamethasone, Spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2013 (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.
The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
Detailed description
The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption 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 |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Morphine, Drug: Zofran, Drug: Paracetamol, Drug: Ibuprofen* Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed * Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. |
| Placebo | Placebo comparator | Other: Placebo, Drug: Morphine, Drug: Zofran, Drug: Paracetamol, Drug: Ibuprofen* Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed * Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing lumbar disc surgery in general anaesthesia.
- Patients who have given their written consent to participate and understand the contents of the protocol.
- ASA 1-3.
- BMI > 18 og < 40.
- Fertile women need a negative HCG urine test.
Key exclusion criteria (8 listed)
- Patients who cannot cooperate to the study.
- Patients who do not speak and/or understand Danish.
- Fertile women with a positive HCG urine test.
- Allergy to the drugs used in the trial.
- Alcohol or medicine abuse, assessed by investigator.
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 |
|---|---|---|
| DexamethasoneIntravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation | Drug | Dexamethasone |
| PlaceboIntravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation | Other | Placebo |
| MorphineMorphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. | Drug | Dexamethasone, Placebo |
| ZofranZofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed | Drug | Dexamethasone, Placebo |
| ParacetamolTablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. | Drug | Dexamethasone, Placebo |
| IbuprofenTablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours. | Drug | Dexamethasone, Placebo |
Primary outcome
Painscore during mobilization
Time frame: 2-24 hours after extubation time.
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.
8 secondary outcomes
Painscore during rest
Time frame: 2-24 hours after extubation time
Morphine consumption
Time frame: 0-24 hours after extubation time.
Painscore during rest and mobilization
Time frame: 48 hours after extubation time
Degree of nausea
Time frame: 2, 4, 8, 12, 24 and 48 hours after extubation time
Incidence of vomiting
Time frame: 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
Zofran consumption
Time frame: 0-24 and 24-48 hours after extubation time.
Degree of sedation
Time frame: 2, 4, 8, 12, 24 and 48 hours after extubation time.
Quality of sleep
Time frame: 24 hours after extubation time.
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 27 Oct 2015.
- Derived from this study: PubMed 27852230Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z.
- Derived from this study: PubMed 26270586Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326.
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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.
Rikke Soennichsen, MD principal investigator
Glostrup University Hospital
Joergen B Dahl, MD study chair
Copenhagen University Hospital, Rigshospitalet
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 Dexamethasone, Morphine and Zofran in people with 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 5 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 27 Oct 2015. 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?
Painscore during mobilization (time frame: 2-24 hours after extubation time.). 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 NCT01953978, which also lists 2 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 27 Oct 2015.