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Epidural PCA on Pain Relief After L-spine Surgery

T

Taipei City Hospital

Status

Completed

Conditions

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

Treatments

Procedure: Epidural patient-controlled analgesia
Procedure: Standard postoperative pain management

Study type

Observational

Funder types

Other

Identifiers

NCT06316921
TCHIRB-11003008-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

209 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

209 participants in 2 patient groups

PCA group
Description:
Patients received epidural patient-controlled analgesia for postoperative pain.
Treatment:
Procedure: Epidural patient-controlled analgesia
Control group
Description:
Patients received standard of care for postoperative pain.
Treatment:
Procedure: Standard postoperative pain management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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