Postoperative AnalgesiaNCT06205199
Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty
A study testing Hydromorphone was injected into the subarachnoid space in people with Postoperative Analgesia, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Hydromorphone was injected into the subarachnoid space
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2022to 30 Nov 2023
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 55 and 80 years old.
- ASA grade I to III.
- BMI:20-29kg/m2.
- No recent use of sedatives, opioids, or other analgesics.
- There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases.
- Patients were willing to participate in the study and signed the informed consent.
Who cannot join
- The patient has mental illness or cannot cooperate with the completion of spinal anesthesia.
- The patient had a history of spinal surgery and spinal deformity.
- Patients had a history of opioid intolerance or adverse reactions.
- puncture site infection, coagulopathy or recent use of anticoagulant drugs.
- History of allergy to local anesthetics.
- Failed puncture.
- Unable to cooperate to complete the research process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty
The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.
Read the detailed description
For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.
- Conditions
- Postoperative Analgesia
- Being tested
- Hydromorphone was injected into the subarachnoid space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone was injected into the subarachnoid spaceDrug
The dose of hydromorphone is 50 micrograms
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone group | Experimental | Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space Receives: Drug: Hydromorphone was injected into the subarachnoid space |
| Control group | No intervention | Ropivacaine 15 mg was injected into the subarachnoid space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
The NRS scale was used to evaluate pain scores at rest at 6, 12, 18, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
Measured: 6, 12, 18, and 24 hours after anesthesia
Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.
NRS rating scale was used to evaluate pain score during movement at 6 hours, 12 hours, 18 hours, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
Measured: 6, 12, 18, and 24 hours after anesthesia
Secondary outcomes (14)
Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia
RASS was used to assess sedation and agitation at 6, 12, 18, and 24 hours after anesthesia；Richmond Agitation and Sedation Scale(RASS,a 10-point scale where -5=unwakeable,0=clear and calm,+4=aggressive)
Measured: 6, 12, 18, and 24 hours after anesthesia
The number of effective compressions of PCIA at 24 hours after surgery
Effective number of PCIA compressions during the 24 hours after surgery
Measured: Postoperative 24 hours
The proportion of the required additional analgesia after 24 hours
The proportion of patients requiring additional analgesia 24 hours after surgery in the whole group
Measured: Postoperative 24 hours
Total non-steroidal analgesic drug consumption 48 hours after surgery
Non-steroidal analgesic consumption at 48 hours after surgery
Measured: Postoperative 48 hours
Total opioid analgesic consumption at 48 hours after surgery
Opioid analgesic consumption at 48 hours after surgery
Measured: Postoperative 48 hours
The proportion of getting out of bed within 48h
The proportion of people who got out of bed 48 hours after operation in the whole group
Measured: Postoperative 48 hours
Satisfaction with postoperative analgesia
Patient satisfaction with postoperative analgesia；0=unsatisfied, 10=fully satisfied
Measured: 5 days after surgery
Retention time of urinary tube
Retention time of urinary catheter after surgery
Measured: 5 days after surgery
Length of postoperative hospital stay
The hospitalization days after surgery
Measured: 2 weeks after surgery
The incidence of postoperative nausea or vomiting
Nausea and vomiting accounted for the proportion of the whole group
Measured: Postoperative 48 hours
The incidence of postoperative pruritus
Pruritus accounted for the proportion of the whole group
Measured: Postoperative 48 hours
The incidence of intraoperative hypotension
Systolic blood pressure drops to 20% of basal blood pressure or systolic blood pressure drops below 90mmHg
Measured: During the operation
The incidence of intraoperative hypoxemia
SpO2 drop below 90%
Measured: During the operation
Incidence of intraoperative HR reduction
HR < 45 beats /min
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start27 Oct 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Tian, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205199
- Sponsor's protocol ID
- 2ed hosp JLU ana dept
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06205199
- Acronym / sponsor ID
- 2ed hosp JLU ana dept
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 12 Jan 2024 (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.
The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.
Detailed description
For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone group | Experimental | Drug: Hydromorphone was injected into the subarachnoid spaceHydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space |
| Control group | No intervention | –Ropivacaine 15 mg was injected into the subarachnoid space |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 55 and 80 years old.
- ASA grade I to III.
- BMI:20-29kg/m2.
- No recent use of sedatives, opioids, or other analgesics.
- There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases.
Key exclusion criteria (7 listed)
- The patient has mental illness or cannot cooperate with the completion of spinal anesthesia.
- The patient had a history of spinal surgery and spinal deformity.
- Patients had a history of opioid intolerance or adverse reactions.
- puncture site infection, coagulopathy or recent use of anticoagulant drugs.
- History of allergy to local anesthetics.
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 |
|---|---|---|
| Hydromorphone was injected into the subarachnoid spaceThe dose of hydromorphone is 50 micrograms | Drug | Hydromorphone group |
Primary outcome
Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
Time frame: 6, 12, 18, and 24 hours after anesthesia
The NRS scale was used to evaluate pain scores at rest at 6, 12, 18, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.
Time frame: 6, 12, 18, and 24 hours after anesthesia
NRS rating scale was used to evaluate pain score during movement at 6 hours, 12 hours, 18 hours, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
14 secondary outcomes
Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia
Time frame: 6, 12, 18, and 24 hours after anesthesia
The number of effective compressions of PCIA at 24 hours after surgery
Time frame: Postoperative 24 hours
The proportion of the required additional analgesia after 24 hours
Time frame: Postoperative 24 hours
Total non-steroidal analgesic drug consumption 48 hours after surgery
Time frame: Postoperative 48 hours
Total opioid analgesic consumption at 48 hours after surgery
Time frame: Postoperative 48 hours
The proportion of getting out of bed within 48h
Time frame: Postoperative 48 hours
Satisfaction with postoperative analgesia
Time frame: 5 days after surgery
Retention time of urinary tube
Time frame: 5 days after surgery
Length of postoperative hospital stay
Time frame: 2 weeks after surgery
The incidence of postoperative nausea or vomiting
Time frame: Postoperative 48 hours
The incidence of postoperative pruritus
Time frame: Postoperative 48 hours
The incidence of intraoperative hypotension
Time frame: During the operation
The incidence of intraoperative hypoxemia
Time frame: During the operation
Incidence of intraoperative HR reduction
Time frame: During the operation
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 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Dan Tian principal investigator
Second Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydromorphone was injected into the subarachnoid space in people with Postoperative Analgesia, run by Second Hospital of Jilin University 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 6 inclusion and 7 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 24 Jan 2024. 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. 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?
Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia. (time frame: 6, 12, 18, and 24 hours after anesthesia). 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 24 Jan 2024.