Epidural PCA on Pain Relief After L-spine Surgery

Completed

• Conditions: Lumbar Spine Degeneration; Pain, Postoperative; Epidural Anesthesia; Analgesia, Patient-Controlled
• Interventions: Procedure: Epidural patient-controlled analgesia; Procedure: Standard postoperative pain management

• Registration Number: NCT06316921
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2024-02-23
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain degree	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 Outcome Measures

Name	Time	Method
The number of morphine injections	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.

Trial Locations

Locations (1)

Taipei City Hospital; 🇨🇳 Taipei, Taiwan