Pain, PostoperativeNCT06316921
Epidural PCA on Pain Relief After L-spine Surgery
An observational study of Pain, Postoperative and Lumbar Spine Degeneration, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pain, Postoperative, Lumbar Spine Degeneration, Analgesia, Patient-Controlled
- What is being tested?
- Standard postoperative pain management
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent lumbar spine surgeries at Taipei City Hospital
Who may be able to join
- Age greater than 60 years
- Having lumbar spine surgeries for degenerative spinal stenosis, spondylolisthesis, herniated intervertebral disc, or osteoporotic spinal fracture with spinal stenosis
Who cannot join
- Spinal infection (e.g., tuberculosis, epidural abscess, and vertebral body osteomyelitis
- Iatrogenic cerebrospinal fluid leakage or dura tear during surgery
- Spinal tumor or spinal metastasis
- Having minimally invasive procedures with the bilateral paramedian approach
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Epidural Patient-controlled Analgesia on Postoperative Pain After Lumbar Spinal Surgeries
This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level.
Read the detailed description
This study included patients who underwent lumbar spine surgeries for degenerative spinal disease. The eligible patients were divided into two groups, the PCA group and the control group, for two types of postoperative pain management. The patients in the PCA group received 72-hour epidural PCA. The PCA catheter was inserted by the surgeon prior to wound closure in the lumbar spine surgery. The PCA catheter was maintained until 72 hours after the surgery and was removed at the postoperative day 4. The control group received postoperative standard pain treatment, including oral acetaminophen and muscle relaxants. No non-steroidal anti-inflammatory drugs were given in this study. All patients were provided the option to request intramuscular morphine injection (0.5 mg of morphine) for additional pain control, with a minimum interval of 6 hours between doses. Pain assessment was conducted using a visual analogue scale on the first four postoperative days and on the day of discharge. At the postoperative day 4, pain assessment was performed before the PCA removal. The level of pain and the number of morphine injections were compared between the two groups.
- Conditions
- Pain, Postoperative, Lumbar Spine Degeneration, Analgesia, Patient-Controlled, Epidural Anesthesia
- Being tested
- Epidural patient-controlled analgesia, Standard postoperative pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural patient-controlled analgesiaProcedure or surgery
Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery
Standard postoperative pain managementProcedure or surgery
Standard of care for postoperative pain after lumber spine surgery
| Study group | Role | What they receive |
|---|---|---|
| PCA group | Patients received epidural patient-controlled analgesia for postoperative pain. Receives: Procedure: Epidural patient-controlled analgesia | |
| Control group | Patients received standard of care for postoperative pain. Receives: Procedure: Standard postoperative pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain degree
Pain degree was assessed using a visual analogue scale the on the first four postoperative days and on the day of discharge.
Measured: Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)
Secondary outcomes (1)
The number of morphine injections
The number of intramuscular morphine injections for additional pain control with a minimum interval of 6 hours between doses.
Measured: The day of discharge (up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hsin-Chang, Chen, Taipei City Hospital
- Investigators
- Hsin-chang Chen, MD, Principal investigator, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316921
- Sponsor's protocol ID
- TCHIRB-11003008-E
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Patient-controlled Analgesia on Postoperative Pain After Lumbar Spinal Surgeries
- ClinicalTrials.gov ID
- NCT06316921
- Acronym / sponsor ID
- TCHIRB-11003008-E
- Conditions
- Pain, Postoperative, Lumbar Spine Degeneration, Analgesia, Patient-Controlled, Epidural Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Mar 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.
This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level.
Detailed description
This study included patients who underwent lumbar spine surgeries for degenerative spinal disease. The eligible patients were divided into two groups, the PCA group and the control group, for two types of postoperative pain management. The patients in the PCA group received 72-hour epidural PCA. The PCA catheter was inserted by the surgeon prior to wound closure in the lumbar spine surgery. The PCA catheter was maintained until 72 hours after the surgery and was removed at the postoperative day 4. The control group received postoperative standard pain treatment, including oral acetaminophen and muscle relaxants. No non-steroidal anti-inflammatory drugs were given in this study. All patients were provided the option to request intramuscular morphine injection (0.5 mg of morphine) for additional pain control, with a minimum interval of 6 hours between doses. Pain assessment was conducted using a visual analogue scale on the first four postoperative days and on the day of discharge. At the postoperative day 4, pain assessment was performed before the PCA removal. The level of pain and the number of morphine injections were compared between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA group | – | Procedure: Epidural patient-controlled analgesiaPatients received epidural patient-controlled analgesia for postoperative pain. |
| Control group | – | Procedure: Standard postoperative pain managementPatients received standard of care for postoperative pain. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lumbar spine surgeries at Taipei City Hospital
Key inclusion criteria (2 listed)
- Age greater than 60 years
- Having lumbar spine surgeries for degenerative spinal stenosis, spondylolisthesis, herniated intervertebral disc, or osteoporotic spinal fracture with spinal stenosis
Key exclusion criteria (4 listed)
- Spinal infection (e.g., tuberculosis, epidural abscess, and vertebral body osteomyelitis
- Iatrogenic cerebrospinal fluid leakage or dura tear during surgery
- Spinal tumor or spinal metastasis
- Having minimally invasive procedures with the bilateral paramedian approach
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 |
|---|---|---|
| Epidural patient-controlled analgesiaEpidural patient-controlled analgesia for postoperative pain after lumber spine surgery | Procedure or surgery | PCA group |
| Standard postoperative pain managementStandard of care for postoperative pain after lumber spine surgery | Procedure or surgery | Control group |
Primary outcome
Pain degree
Time frame: Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)
Pain degree was assessed using a visual analogue scale the on the first four postoperative days and on the day of discharge.
1 secondary outcome
The number of morphine injections
Time frame: The day of discharge (up to 1 month)
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 19 Mar 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.
Hsin-chang Chen, MD principal investigator
Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Lumbar Spine Degeneration, run by Taipei City Hospital at 1 site in Taiwan.
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 4 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 19 Mar 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 Taiwan. 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?
Pain degree (time frame: Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)). 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 19 Mar 2024.