Epidural PCA on Pain Relief After L-spine Surgery

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lumbar spine surgeries at Taipei City Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCA group; Patients received epidural patient-controlled analgesia for postoperative pain.	Procedure: Epidural patient-controlled analgesia; Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery
Control group; Patients received standard of care for postoperative pain.	Procedure: Standard postoperative pain management; Standard of care for postoperative pain after lumber spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain degree	Pain degree was assessed using a visual analogue scale the on the first four postoperative days and on the day of discharge.	Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of morphine injections	The number of intramuscular morphine injections for additional pain control with a minimum interval of 6 hours between doses.	The day of discharge (up to 1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization	The length of hospital stay (day)	The day of discharge (up to 1 month)
Drainage amount	The amount of postoperative drainage (ml)	The day of discharge (up to 1 month)

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Principal Investigator: Hsin-chang Chen, MD, Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: TCHIRB-11003008-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No