DexamethasoneNCT04767256
Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block
A study testing Dexamethasone and dexmedetomidine, Dexmedetomidine and Ultrasound-guided lumbar erector spinae plane block in people with Dexamethasone and Dexmedetomidine, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexamethasone, Dexmedetomidine, Nerve Block
- What is being tested?
- Dexamethasone and dexmedetomidine, Dexmedetomidine and Ultrasound-guided lumbar erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Involvement of ≤3 spinal levels
- Undergo elective posterior lumbar interbody fusion
- Informed consent
Who cannot join
- A known allergy to the drugs being used
- Pre-existing neuropsychiatric disorders or language barrier
- Analgesics intake, history of substance abuse
- Contraindications to peripheral nerve block
- Acute cerebrovascular disease
- Severe liver failure
- Uncontrolled low blood pressure
- Sinus bradycardia or atrioventricular block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block for Posterior Lumbar Interbody Fusion Surgery
Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic pain syndromes. Pain after spinal surgery can arise from several different tissues, such as the vertebrae, disks, ligaments, dura, facet joint, muscle, fascia, and subcutaneous and cutaneous tissues.
Ultrasound-guided lumbar erector spinae plane block (ESPB) has been shown to reduce postoperative pain in patients undergoing posterior lumbar interbody fusion (PLIF). However, the duration of analgesia after single-shot ESPB with commonly used local anesthetics is reported to be no more than 12 h, which often not long enough to provide satisfactory postoperative pain relief, as the pain typically lasts for several days. Compared with perineural route, intravenous additives to local anesthetics are commonly accepted as its safety and efficiency have been reported. Moreover, co-administration of intravenous dexamethasone and dexmedetomidine significantly prolonged the time to first rescue analgesic request after single-shot interscalene brachial plexus block. However, more data are needed especially for lumbar ESPB.
- Conditions
- Dexamethasone, Dexmedetomidine, Nerve Block
- Being tested
- Dexamethasone and dexmedetomidine, Dexmedetomidine, Ultrasound-guided lumbar erector spinae plane block, PCIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone and dexmedetomidineDrug
General anesthesia was induced with sufentanil 0.5-0.8 ug/kg, propofol 1.5-2.0 mg/kg, and rocuronium 0.5-1.0 mg/kg. Intravenous dexamethasone 10 mg was injected and a 50-ml syringe containing dexmedetomidine 1 ug/kg in 0.9% saline was infused after induction of general anaesthesia over a 30-min period. Anesthesia was maintained by remifentanil and sevoflurane to keep the Narcotrend index reading between 40 and 60.
DexmedetomidineDrug
Intravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period.
Ultrasound-guided lumbar erector spinae plane blockOther
The probe was installed in the sagittal axis in the midline at the L3 vertebral level. The spinous processes were first visualized, after which the probe was lateralized, and the transverse processes and the erector spinae muscle were visualized approximately 3 cm laterally to the midline. The needle was advanced between the transverse process and the deep fascia of the erector spinae muscle from the caudal to the cranial using in-plane technique. The location of the needle was confirmed with 2mL saline solution, after which 20 mL of 0.4% ropivacaine was administered.
PCIAOther
Intravenous PCA included 0.9% saline with sufentanil and was programmed to run at 2ml with a 1-ml bolus dose and a 10-min lockout time. The patients with VAS more than 4 despite using intravenous PCA were treated with rescue analgesics comprising intravenous parecoxib.
| Study group | Role | What they receive |
|---|---|---|
| DD group | Experimental | co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg Receives: Drug: Dexamethasone and dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA |
| D group | Placebo comparator | intravenous dexmedetomidine 1 ug/kg Receives: Drug: Dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative opioid consumption
Measured: At 24 postoperative hours
The time to first rescue analgesic request
Measured: Up to 48 postoperative hrs
Secondary outcomes (4)
The pain scores determined by the numeric rating scale (NRS, 0-10)
Measured: At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery
Incidence of postoperative nausea and vomiting
Measured: Up to 24 postoperative hrs
Postoperative hospital length of stay
Measured: Up to 3 weeks
Adverse events
Measured: Up to 48 postoperative hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021
- Primary completion22 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Wu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767256
- Sponsor's protocol ID
- XH20210202
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block for Posterior Lumbar Interbody Fusion Surgery
- ClinicalTrials.gov ID
- NCT04767256
- Acronym / sponsor ID
- XH20210202
- Conditions
- Dexamethasone, Dexmedetomidine, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 22 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 23 Feb 2021 (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.
Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic pain syndromes. Pain after spinal surgery can arise from several different tissues, such as the vertebrae, disks, ligaments, dura, facet joint, muscle, fascia, and subcutaneous and cutaneous tissues.
Ultrasound-guided lumbar erector spinae plane block (ESPB) has been shown to reduce postoperative pain in patients undergoing posterior lumbar interbody fusion (PLIF). However, the duration of analgesia after single-shot ESPB with commonly used local anesthetics is reported to be no more than 12 h, which often not long enough to provide satisfactory postoperative pain relief, as the pain typically lasts for several days. Compared with perineural route, intravenous additives to local anesthetics are commonly accepted as its safety and efficiency have been reported. Moreover, co-administration of intravenous dexamethasone and dexmedetomidine significantly prolonged the time to first rescue analgesic request after single-shot interscalene brachial plexus block. However, more data are needed especially for lumbar ESPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD group | Experimental | Drug: Dexamethasone and dexmedetomidine, Other: Ultrasound-guided lumbar erector spinae plane block, Other: PCIAco-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg |
| D group | Placebo comparator | Drug: Dexmedetomidine, Other: Ultrasound-guided lumbar erector spinae plane block, Other: PCIAintravenous dexmedetomidine 1 ug/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Involvement of ≤3 spinal levels
- Undergo elective posterior lumbar interbody fusion
- Informed consent
Key exclusion criteria (8 listed)
- A known allergy to the drugs being used
- Pre-existing neuropsychiatric disorders or language barrier
- Analgesics intake, history of substance abuse
- Contraindications to peripheral nerve block
- Acute cerebrovascular disease
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 |
|---|---|---|
| Dexamethasone and dexmedetomidineGeneral anesthesia was induced with sufentanil 0.5-0.8 ug/kg, propofol 1.5-2.0 mg/kg, and rocuronium 0.5-1.0 mg/kg. Intravenous dexamethasone 10 mg was injected and a 50-ml syringe containing dexmedetomidine 1 ug/kg in 0.9% saline was infused after induction of general anaesthesia over a 30-min period. Anesthesia was maintained by remifentanil and sevoflurane to keep the Narcotrend index reading between 40 and 60. | Drug | DD group |
| DexmedetomidineIntravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period. | Drug | D group |
| Ultrasound-guided lumbar erector spinae plane blockThe probe was installed in the sagittal axis in the midline at the L3 vertebral level. The spinous processes were first visualized, after which the probe was lateralized, and the transverse processes and the erector spinae muscle were visualized approximately 3 cm laterally to the midline. The needle was advanced between the transverse process and the deep fascia of the erector spinae muscle from the caudal to the cranial using in-plane technique. The location of the needle was confirmed with 2mL saline solution, after which 20 mL of 0.4% ropivacaine was administered. | Other | D group, DD group |
| PCIAIntravenous PCA included 0.9% saline with sufentanil and was programmed to run at 2ml with a 1-ml bolus dose and a 10-min lockout time. The patients with VAS more than 4 despite using intravenous PCA were treated with rescue analgesics comprising intravenous parecoxib. | Other | D group, DD group |
Primary outcome
The cumulative opioid consumption
Time frame: At 24 postoperative hours
The time to first rescue analgesic request
Time frame: Up to 48 postoperative hrs
4 secondary outcomes
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time frame: At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 postoperative hrs
Postoperative hospital length of stay
Time frame: Up to 3 weeks
Adverse events
Time frame: Up to 48 postoperative hrs
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 29 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Dexamethasone
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
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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 study testing Dexamethasone and dexmedetomidine, Dexmedetomidine and Ultrasound-guided lumbar erector spinae plane block in people with Dexamethasone and Dexmedetomidine, run by Huazhong University of Science and Technology at 1 site in China.
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 29 Mar 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 China. 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?
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?
The cumulative opioid consumption (time frame: At 24 postoperative hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2022.