Postoperative Drains for Lumbar Fusion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rothman Institute Orthopaedics

Disqualifiers: Revision surgery, Infection, Dural tear, Transfusion

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment No Postoperative Drain Placement, Postoperative Drain Placement for lumbar fusion?

Research shows that using drains in lumbar spine surgeries, like lumbar fusion, does not significantly affect infection rates or wound healing. This suggests that not using a drain might be just as effective as using one in terms of preventing complications. ^{1 2 3 4 5}

Is it safe to use postoperative drains in lumbar fusion surgery?

The studies reviewed do not specifically address the safety of using postoperative drains in lumbar fusion surgery. However, they do mention complications like cerebrospinal fluid leaks and bleeding, which are general risks associated with lumbar fusion procedures. ^{1 6 7 8 9}

How does the treatment of not using postoperative drains in lumbar fusion differ from other treatments?

Not using postoperative drains in lumbar fusion is unique because it avoids the potential complications associated with drains, such as prolonged hospital stay and patient discomfort, without increasing the risk of infection or affecting wound healing, as shown in studies comparing outcomes with and without drains. ^{1 2 3 5 10}

What is the purpose of this trial?

Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression. The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain

Eligibility Criteria

This trial is for patients undergoing primary lumbar fusion surgery. It's designed to see if using a drain after the operation helps or not. People with certain health conditions that could affect their participation are excluded, but specific criteria aren't listed here.

Inclusion Criteria

I am older than 18.

I am having a spine surgery involving 1-2 levels of my lower back.

I need surgery for my lower back condition.

Exclusion Criteria

I need surgery due to an infection.

I experienced a tear in the dura during surgery.

I had surgery that needed blood transfusion during the operation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo primary lumbar fusion surgery with or without postoperative drain placement

1 week

Inpatient hospital stay

Follow-up

Participants are monitored for postoperative complications and outcomes

1 year

Regular follow-up visits

Treatment Details

Interventions

• No Postoperative Drain Placement
• Postoperative Drain Placement

Trial Overview The study compares outcomes of lumbar fusion surgery between two groups: one has a postoperative drain placed to prevent fluid buildup and complications; the other does not use a drain.

Participant Groups

Group I: Group 1: Postoperative Drain Group Active Control 1 Intervention

Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively

Group II: Group 2: No Postoperative Drain Group Active Control 1 Intervention

Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of drains in lumbar spine fusion. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of closed wound suction drainage after single-level lumbar laminectomy. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Negative versus natural drainage after single-level posterior lumbar interbody fusion. A prospective randomized study. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Application of modified alternate negative pressure drainage instrument after posterior lumbar fusion]. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Wound drain in lumbar arthrodesis for degenerative disease: an experimental, multicenter, randomized controlled trial. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Cerebrospinal fluid (CSF) leak after elective lumbar spinal fusion: Who is at risk? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of perioperative complications on clinical outcome scores in lumbar fusion surgery. [2013]

8. France pubmed.ncbi.nlm.nih.gov

[Intraoperative and early postoperative complications of lumbar and lumbosacral fusion: prospective analysis of 872 patients]. [2019]

9. Scotland pubmed.ncbi.nlm.nih.gov

Clinical implication of complications on patient perceived health status following spinal fusion surgery. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of postoperative wound drains in one- and two-level cervical spine fusions. [2022]