Epidural PCA on Pain Relief After L-spine Surgery

March 16, 2024 updated by: Hsin-Chang, Chen, Taipei City Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent lumbar spine surgeries at Taipei City Hospital

Description

Inclusion Criteria:

  1. Age greater than 60 years
  2. Having lumbar spine surgeries for degenerative spinal stenosis, spondylolisthesis, herniated intervertebral disc, or osteoporotic spinal fracture with spinal stenosis

Exclusion Criteria:

  1. Spinal infection (e.g., tuberculosis, epidural abscess, and vertebral body osteomyelitis
  2. Iatrogenic cerebrospinal fluid leakage or dura tear during surgery
  3. Spinal tumor or spinal metastasis
  4. Having minimally invasive procedures with the bilateral paramedian approach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PCA group
Patients received epidural patient-controlled analgesia for postoperative pain.
Procedure: Epidural patient-controlled analgesia
Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery
Control group
Patients received standard of care for postoperative pain.
Procedure: Standard postoperative pain management
Standard of care for postoperative pain after lumber spine surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of morphine injections
Time Frame: The day of discharge (up to 1 month)
The number of intramuscular morphine injections for additional pain control with a minimum interval of 6 hours between doses.
The day of discharge (up to 1 month)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: The day of discharge (up to 1 month)
The length of hospital stay (day)
The day of discharge (up to 1 month)
Drainage amount
Time Frame: The day of discharge (up to 1 month)
The amount of postoperative drainage (ml)
The day of discharge (up to 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsin-chang Chen, MD, Taipei City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCHIRB-11003008-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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