Epidural PCA on Pain Relief After L-spine Surgery

NCT06316921 | Completed

• 1 other identifier: TCHIRB-11003008-E
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of morphine injections

  The day of discharge (up to 1 month)

Other Outcomes (2)

• Length of hospitalization

  The day of discharge (up to 1 month)

• Drainage amount

  The day of discharge (up to 1 month)

Study Arms (2)

PCA group

Patients received epidural patient-controlled analgesia for postoperative pain.

Procedure: Epidural patient-controlled analgesia

Control group

Patients received standard of care for postoperative pain.

Procedure: Standard postoperative pain management

Interventions

Epidural patient-controlled analgesia PROCEDURE

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

PCA group

Standard postoperative pain management PROCEDURE

Standard of care for postoperative pain after lumber spine surgery

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lumbar spine surgeries at Taipei City Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Hsin-chang Chen, MD

  Taipei City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending staff of the Department of Orthopedics,

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 19, 2024
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)