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Completed

NCT Number: NCT06316921

Epidural PCA on Pain Relief After L-spine Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Epidural patient-controlled analgesia

Procedure

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

Standard postoperative pain management

Procedure

Standard of care for postoperative pain after lumber spine surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Length of hospitalization

    Time frame: The day of discharge (up to 1 month)

    The length of hospital stay (day)

  2. Drainage amount

    Time frame: The day of discharge (up to 1 month)

    The amount of postoperative drainage (ml)

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

Effect of Epidural Patient-controlled Analgesia on Postoperative Pain After Lumbar Spinal Surgeries

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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