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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of using or not using a drain after lumbar fusion surgery, a procedure for back problems like lumbar degenerative disease. Drains often reduce complications such as hematomas (blood clots) and infections but may also lead to increased blood loss and longer hospital stays. The study compares outcomes for patients with drains placed after surgery versus those without postoperative drain placement. Suitable candidates for this trial are adults undergoing their first lumbar fusion surgery for 1-2 levels due to degenerative back disease. The trial aims to determine if skipping the drain can lead to better or similar recovery results. As an unphased trial, it offers patients the opportunity to contribute to understanding and potentially improving post-surgery recovery methods.

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 prior data suggests that postoperative drain placement is safe for lumbar fusion surgery?

Research has shown mixed results regarding the use of drains after spine surgery, such as lumbar fusion. Some studies suggest that drains do not consistently reduce the risk of surgical site complications, like infections or blood clots. Other research indicates that early removal of drains can shorten hospital stays without increasing these risks.

Overall, using drains can sometimes lead to issues such as infections spreading back into the body, increased blood loss, and longer hospital stays. The evidence on their safety and effectiveness remains inconclusive. Consequently, while some patients might benefit from drains, for others, avoiding a drain could be equally safe or even safer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of postoperative drains for lumbar fusion because it could redefine how we approach recovery after spine surgery. Traditionally, surgeons have used drains to remove excess fluids and reduce infection risk after lumbar fusion. However, this trial explores the possibility of skipping the drain entirely. The unique aspect is that it could lead to a simpler recovery process, with potentially fewer complications and discomfort for patients. If successful, it might streamline postoperative care, making spine surgery less daunting.

What evidence suggests that this trial's treatments could be effective for lumbar fusion surgery?

Research has shown that using drains after back surgery might not be as beneficial as once believed. In this trial, participants will be divided into two groups: one group will have a postoperative drain placed, while the other will not. Some studies have found that patients with drains often stay in the hospital longer than those without. For example, one study found that patients with drains stayed about 39 hours, while those without stayed around 32 hours. Drains also carry a higher risk of problems like infections and increased blood loss. Although drains are intended to prevent issues like blood clots, recent evidence suggests they may not provide significant benefits and could even cause other problems. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 am scheduled for a corrective surgery.

I need surgery due to an infection.

I experienced a tear in the dura during surgery.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6046317/

Post-operative drain use in patients undergoing ... demonstrated that patients with postoperative wound drains experienced significantly longer LOS when compared to patients without a drain (38.9 vs. 31.7 hours, ...

2. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02726-3

Advancing the timing of drainage removal: a comprehensive ... In this study, we found that the relaxation of the criteria for drainage removal could significantly shorten the LOS, in addition, it could ...

3. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/41/2/article-p216.xml

Safety of early discharge after elective lumbar spine surgery ... Outpatient drain removal after elective lumbar spine surgery was associated with a significantly decreased LOS without a significant increase in postoperative ...

4. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1213&context=rothman_institute

Effect of Drain Duration and Output on Perioperative ... Postoperative drains have been used by surgeons to mini- mize complications of lumbar spine surgery in over 10% of patients [1]. However, the ...

5. aofoundation.org aofoundation.org/spine/about-aospine/blog/2024_04-blog-drains-lumbar-surgery

Using post-operative drains in lumbar surgery—time for a ... Increasingly, research shows that the use of drains in post-operative lumbar surgery has few or no benefits—and may even have downsides.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11673855/

Advancing the timing of drainage removal In addition, numerous Mata-analysis indicated that routine use of drainage in lumbar spinal surgery did not reduce the risk of surgical site ...

7. unmc.edu unmc.edu/com/_documents/research/mssrp_2025_abstracts_-_drew_hedstrom.pdf

Post Operative Outcomes Comparing Drain vs. No ... Many spine surgeons use drains to reduce the risk of postoperative hematoma, infection, or wound dehiscence, but outcomes are inconsistent, and decisions are.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1529943022010415

Wound drain in lumbar arthrodesis for degenerative disease We aimed to evaluate wound drains in patients with lumbar arthrodesis for degenerative disorders based on clinical outcomes, complications, hematocrit, and ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2020/02140/drainage_after_posterior_single_level_instrumented.68.aspx

Drainage after posterior single-level instrumented lumbar... This study is to compare the clinical outcomes between natural pressure drainage and negative pressure drainage after posterior lumbar interbody fusion.