Rebound PainNCT05825378
The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery
A study testing Dexamethasone 8mg+0.375% ropivacaine and 0.375% ropivacaine in people with Rebound Pain and Dexamethasone, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Regional nerve block is one of the commonly used methods for postoperative analgesia after thoracoscopic surgery. Recent studies have found that rebound pain may occur after regional block, which is defined as acute postoperative pain that occurs after the resolution of sensory block related to regional anesthesia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rebound Pain, Dexamethasone, Intercostal Nerve Block
- What is being tested?
- Dexamethasone 8mg+0.375% ropivacaine and 0.375% ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 6 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective thoracoscopic surgery Age > 18 years old ASA ⅰ-ⅲ Informed consent was signed
Who cannot join
- Patients with aoagulation disorders Patients with allergy to local anesthetics Patients with severe cardiopulmonary diseases Patients had systemic steroid use Patients with chronic pain Patients with uncontrolled diabetes and mental disorders History of drug abuse; Body Mass Index more than 35 kg.m-2 Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
About this study
Official title: The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery: a Randomized, Double-blind, Controlled Study
Regional nerve block is one of the commonly used methods for postoperative analgesia after thoracoscopic surgery. Recent studies have found that rebound pain may occur after regional block, which is defined as acute postoperative pain that occurs after the resolution of sensory block related to regional anesthesia, and seriously affects the quality of postoperative recovery of patients. There is evidence that rebound tenderness is associated with local anesthetic toxicity and proinflammatory effects. The aim of this study was to investigate the effect of dexamethasone on rebound pain after a single intercostal nerve block in patients undergoing thoracoscopic surgery.
- Being tested
- Dexamethasone 8mg+0.375% ropivacaine, 0.375% ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 8mg+0.375% ropivacaineDrug
Ultrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml of a mixture of 0.375% ropivacaine and 8 mg dexamethasone was injected at each point
0.375% ropivacaineDrug
Ultrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml 0.375% ropivacaine was injected at each point
| Study group | Role | What they receive |
|---|---|---|
| group dexamethasone | Experimental | Dexamethasone 8mg+0.375% ropivacaine Receives: Drug: Dexamethasone 8mg+0.375% ropivacaine |
| group control | Sham comparator | 0.375% ropivacaine Receives: Drug: 0.375% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of rebound pain after the disappearance of nerve block effect
NRS < 3 in PACU and NRS > 7 after the disappearance of nerve block effect
Measured: 8 hours after the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion5 May 2025 (estimated)
- Study completion6 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rebound PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825378
- Sponsor's protocol ID
- 20230411
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery: a Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT05825378
- Acronym / sponsor ID
- 20230411
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 6 Aug 2025 (estimated)
- First posted
- 24 Apr 2023 (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.
Regional nerve block is one of the commonly used methods for postoperative analgesia after thoracoscopic surgery. Recent studies have found that rebound pain may occur after regional block, which is defined as acute postoperative pain that occurs after the resolution of sensory block related to regional anesthesia, and seriously affects the quality of postoperative recovery of patients. There is evidence that rebound tenderness is associated with local anesthetic toxicity and proinflammatory effects. The aim of this study was to investigate the effect of dexamethasone on rebound pain after a single intercostal nerve block in patients undergoing thoracoscopic surgery.
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 |
|---|---|---|
| group dexamethasone | Experimental | Drug: Dexamethasone 8mg+0.375% ropivacaineDexamethasone 8mg+0.375% ropivacaine |
| group control | Sham comparator | Drug: 0.375% ropivacaine0.375% ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective thoracoscopic surgery Age > 18 years old ASA ⅰ-ⅲ Informed consent was signed
Key exclusion criteria (1 listed)
- Patients with aoagulation disorders Patients with allergy to local anesthetics Patients with severe cardiopulmonary diseases Patients had systemic steroid use Patients with chronic pain Patients with uncontrolled diabetes and mental disorders History of drug abuse; Body Mass Index more than 35 kg.m-2 Pregnant or breastfeeding woman.
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 8mg+0.375% ropivacaineUltrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml of a mixture of 0.375% ropivacaine and 8 mg dexamethasone was injected at each point | Drug | group dexamethasone |
| 0.375% ropivacaineUltrasound-guided intercostal nerve block was performed on the surgical side, and 3 to 5ml 0.375% ropivacaine was injected at each point | Drug | group control |
Primary outcome
The incidence of rebound pain after the disappearance of nerve block effect
Time frame: 8 hours after the nerve block
NRS < 3 in PACU and NRS > 7 after the disappearance of nerve block effect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Rebound Pain
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Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
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Rebound Pain, Shoulder Arthroplasty
Not yet recruitingPhase 4
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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.
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 8mg+0.375% ropivacaine and 0.375% ropivacaine in people with Rebound Pain and Dexamethasone, run by Beijing Tiantan Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D., PhD. (8610-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of rebound pain after the disappearance of nerve block effect (time frame: 8 hours after the nerve block). 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 24 Apr 2023.