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NCT Number: NCT07837427

Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery

This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. During this surgery, fluid is used to keep the surgical area clear and to control bleeding. The pressure of this fluid may affect how clear the surgical view is, how much bleeding occurs, and how well patients recover after surgery. We will also collect disc tissue removed during surgery to study how disc degeneration is related to factors such as sex, age, mechanical stress, and injury. About 80 patients aged 18 to 75 who are scheduled for UBE surgery at our hospital will take part. Patients will be randomly assigned to one of four groups based on two things: the height of the fluid bag (0.9 meters or 1.0 meters) and the direction of the surgical cut (horizontal or vertical). We will measure the fluid pressure around the spinal covering during surgery and record how clear the surgical view is. After surgery, we will track patients' pain and recovery for at least 6 months. This study has been approved by the hospital ethics committee.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location status: Recruiting

Location contact

Fan Zhang, MD

CONTACT

[email protected]

+86 15087160418

About this study

Background: Unilateral biportal endoscopy (UBE) is a minimally invasive spine surgery technique that has been increasingly used for lumbar disc herniation, spinal stenosis, and other degenerative conditions. Irrigation fluid is essential in UBE to maintain the surgical space and control bleeding. However, the pressure of irrigation fluid may be associated with complications such as neck pain, seizures, and increased intracranial pressure. The height of the fluid bag and the direction of the surgical incision are two controllable factors that may influence actual irrigation pressure and surgical field clarity, but prospective clinical evidence is lacking.

Objective: This study aims to investigate the effects of different fluid bag heights (0.9 m vs. 1.0 m) and incision directions (horizontal vs. vertical) on irrigation pressure, surgical field clarity, blood loss, and early postoperative pain and functional recovery in patients undergoing UBE surgery. Additionally, disc tissue collected during surgery will be used to explore the relationship between disc degeneration and factors such as sex, age, mechanical stress, and injury.

Design: This is a single-center, prospective, randomized controlled trial. Approximately 80 patients scheduled for UBE surgery at the First Affiliated Hospital of Kunming Medical University will be enrolled. Patients will be randomly assigned to one of four groups: (1) 0.9 m fluid bag height + horizontal incision; (2) 0.9 m fluid bag height + vertical incision; (3) 1.0 m fluid bag height + horizontal incision; (4) 1.0 m fluid bag height + vertical incision. Intraoperative irrigation pressure around the dura will be continuously measured. Surgical field clarity, blood loss, and early postoperative outcomes will be recorded. Patients will be followed for at least 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years and < 75 years.
  • Patients scheduled for unilateral biportal endoscopic (UBE) surgery for lumbar degenerative disease at the First Affiliated Hospital of Kunming Medical University between February 2026 and December 2027.
  • Follow-up duration > 6 months.
  • Complete clinical and follow-up data available.
  • Voluntary participation and signed informed consent.

Exclusion criteria

  • History of tuberculosis, infection, tumor, or trauma.
  • Severe cardiac, hepatic, or renal insufficiency.
  • History of chronic lung disease, liver disease, HIV infection, diabetes, or renal insufficiency.
  • Psychiatric disorders or inability to comply with follow-up.
  • Severe osteoporosis.
  • Pregnant or lactating women.

Treatment and study plan

Unilateral biportal endoscopic surgery

Procedure

UBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal).

Primary outcomes

  1. Irrigation pressure around the dura

    Time frame: During surgery

    Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Fan Zhang, MD

CONTACT

[email protected]

+86 15087160418

Sponsors and collaborators

Lead sponsor

Fan Zhang

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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