Clinical trial NCT06316921: Epidural PCA on Pain Relief After L-spine Surgery
Official title: Effect of Epidural Patient-controlled Analgesia on Postoperative Pain After Lumbar Spinal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lumbar Spine Degeneration
Analgesia, Patient-Controlled
Epidural Anesthesia
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-19
Enrollment: 209
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent lumbar spine surgeries at Taipei City Hospital

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain degree
timeFrame: Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)
Secondary outcomes:
measure: The number of morphine injections
timeFrame: The day of discharge (up to 1 month)
Other outcomes:
measure: Length of hospitalization
timeFrame: The day of discharge (up to 1 month)
measure: Drainage amount
timeFrame: The day of discharge (up to 1 month)
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: Hsin-chang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: