Postoperative PainPhase 4NCT03527576
Block Duration After Spinal Block and iv Dexamethasone.
A Phase 4 study testing Dexamethasone and NaCl 0.0308 MEQ/ML Injectable Solution in people with Postoperative Pain and Lower Limb Injury, run by Eric Albrecht at 1 site in Switzerland.
Trial summary
It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Lower Limb Injury
- What is being tested?
- Dexamethasone and NaCl 0.0308 MEQ/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2018to 1 Apr 2022
- 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
- Patient with ASA I-III status ;
- Patient scheduled for an osteosynthesis surgy of the lower limb
Who cannot join
- Polytrauma patient
- Pregnancy
- Contraindication to spinal anesthesia
- Contraindication to dexamethasone administration
- Patient with chronic pain
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.
- Conditions
- Postoperative Pain, Lower Limb Injury
- Being tested
- Dexamethasone, NaCl 0.0308 MEQ/ML Injectable Solution
- Medical subject headings
- Pain, Postoperative, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
NaCl 0.0308 MEQ/ML Injectable SolutionDrug
Intravenous injection of NaCl 0.9% before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery. Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Intravenous injection of NaCl 0,9% before the surgery. Receives: Drug: NaCl 0.0308 MEQ/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block (minutes)
Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached
Measured: Postoperative day 0
Secondary outcomes (14)
Highest dermatoma reached (level)
Measured: Postoperative day 0
Onset time between injection and highest dermatoma (minutes)
Measured: Postoperative day 0
Total duration of the sensory block (minutes)
Measured: Postoperative day 0
Total duration of the motor block (minutes)
Measured: Postoperative day 0
Time to the first analgesic request (minutes)
Measured: Postoperative day 0
Cumulative consumption of morphine (mg)
Measured: Postoperative days 0, 1 and 2
Pain score
Numeric rating scale (0-10)
Measured: Postoperative days 0, 1 and 2
Rate of postoperative nausea and vomiting
YES/NO
Measured: Postoperative day 0, 1 and 2
Rate of pruritus
YES/NO
Measured: Postoperative day 0, 1 and 2
Rate of urinary retention
YES/NO
Measured: Postoperative day 1 and 2
Satisfaction level
Numeric rating scale (0-10)
Measured: Postoperative day 2
Length of stay
Days
Measured: up to 14 days
Persistent pain
YES/NO
Measured: 3 and 6 postoperative months
Pain score if persistent pain
Numeric rating scale (0-10)
Measured: 3 and 6 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 May 2018
- Primary completion1 Nov 2021
- Study completion1 Apr 2022
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.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527576
- Sponsor's protocol ID
- CER 2018-00500
- Status last verified
- Jul 2022
- First submitted
- 4 May 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bikfalvi A, Hofmann G, Bashawyah A, Rossel JB, Gonvers E, Albrecht E. Sensory block duration after spinal anaesthesia supplemented with intravenous dexamethasone: a randomised controlled double-blinded trial. Br J Anaesth. 2023 Jun;130(6):780-785. doi: 10.1016/j.bja.2023.02.027. Epub 2023 Mar 23.
PubMed 36966023
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT03527576
- Acronym / sponsor ID
- CER 2018-00500
- Conditions
- Postoperative Pain, Lower Limb Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.
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 |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneIntravenous injection of 0.15 mg/kg of dexamethasone before the surgery. |
| Placebo | Placebo comparator | Drug: NaCl 0.0308 MEQ/ML Injectable SolutionIntravenous injection of NaCl 0,9% before the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with ASA I-III status ;
- Patient scheduled for an osteosynthesis surgy of the lower limb
Key exclusion criteria (5 listed)
- Polytrauma patient
- Pregnancy
- Contraindication to spinal anesthesia
- Contraindication to dexamethasone administration
- Patient with chronic pain
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 injection of 0.15 mg/kg of dexamethasone before the surgery. | Drug | Dexamethasone |
| NaCl 0.0308 MEQ/ML Injectable SolutionIntravenous injection of NaCl 0.9% before the surgery. | Drug | Placebo |
Primary outcome
Duration of sensory block (minutes)
Time frame: Postoperative day 0
Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached
14 secondary outcomes
Highest dermatoma reached (level)
Time frame: Postoperative day 0
Onset time between injection and highest dermatoma (minutes)
Time frame: Postoperative day 0
Total duration of the sensory block (minutes)
Time frame: Postoperative day 0
Total duration of the motor block (minutes)
Time frame: Postoperative day 0
Time to the first analgesic request (minutes)
Time frame: Postoperative day 0
Cumulative consumption of morphine (mg)
Time frame: Postoperative days 0, 1 and 2
Pain score
Time frame: Postoperative days 0, 1 and 2
Rate of postoperative nausea and vomiting
Time frame: Postoperative day 0, 1 and 2
Rate of pruritus
Time frame: Postoperative day 0, 1 and 2
Rate of urinary retention
Time frame: Postoperative day 1 and 2
Satisfaction level
Time frame: Postoperative day 2
Length of stay
Time frame: up to 14 days
Persistent pain
Time frame: 3 and 6 postoperative months
Pain score if persistent pain
Time frame: 3 and 6 postoperative months
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 20 Jul 2022.
- Derived from this study: PubMed 36966023Bikfalvi A, Hofmann G, Bashawyah A, Rossel JB, Gonvers E, Albrecht E. Sensory block duration after spinal anaesthesia supplemented with intravenous dexamethasone: a randomised controlled double-blinded trial. Br J Anaesth. 2023 Jun;130(6):780-785. doi: 10.1016/j.bja.2023.02.027. Epub 2023 Mar 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and NaCl 0.0308 MEQ/ML Injectable Solution in people with Postoperative Pain and Lower Limb Injury, run by Eric Albrecht at 1 site in Switzerland.
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 5 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 20 Jul 2022. 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 Switzerland. 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?
Duration of sensory block (minutes) (time frame: Postoperative day 0). 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 NCT03527576, 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 20 Jul 2022.