Epidural PCA on Pain Relief After L-spine Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316921
• Other study ID #: TCHIRB-11003008-E
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2024
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Epidural patient-controlled analgesia
Epidural patient-controlled analgesia for postoperative pain after lumber spine surgery
• Standard postoperative pain management
Standard of care for postoperative pain after lumber spine surgery

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospitalization	The length of hospital stay (day)	The day of discharge (up to 1 month)
Other	Drainage amount	The amount of postoperative drainage (ml)	The day of discharge (up to 1 month)
Primary	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	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)