Epidural PCA on Pain Relief After L-spine Surgery

NCT ID: NCT06316921

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Pain, Postoperative Lumbar Spine Degeneration Analgesia, Patient-Controlled Epidural Anesthesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PCA group

Patients received epidural patient-controlled analgesia for postoperative pain.

Epidural patient-controlled analgesia

Intervention Type PROCEDURE

Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery

Control group

Patients received standard of care for postoperative pain.

Standard postoperative pain management

Intervention Type PROCEDURE

Standard of care for postoperative pain after lumber spine surgery

Interventions

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Epidural patient-controlled analgesia

Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery

Intervention Type PROCEDURE

Standard postoperative pain management

Standard of care for postoperative pain after lumber spine surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hsin-Chang, Chen

Attending staff of the Department of Orthopedics,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsin-chang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei City Hospital

Locations

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Taipei City Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TCHIRB-11003008-E

Identifier Type: -

Identifier Source: org_study_id

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