Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07401641

Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap Survival in Oral Cancer Radical Surgery: A Randomized Controlled Trial

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-10

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two pain relief methods for patients undergoing oral cancer radical surgery with free flap reconstruction. The study evaluates the effects of combining sufentanil with either dezocine or nalbuphine on postoperative pain, complications, and flap survival. Both drugs are opioid agonist-antagonists, possibly offering better safety than traditional opioids like sufentanil alone. This is a prospective, randomized, double-blind, controlled clinical trial involving 60 patients aged 18 to 70 years. Participants are randomly assigned to one of two groups receiving patient-controlled intravenous analgesia (PCIA) after surgery. One group receives sufentanil combined with dezocine, while the other receives sufentanil combined with nalbuphine. Both combinations are diluted to 150 ml with normal saline and administered via a PCIA pump that delivers a 2.5 ml bolus with a 15-minute lockout and no basal infusion. This intervention starts at the end of surgery, with standardized general anesthesia used for all patients. Throughout the study, patients' pain intensity is measured using the Visual Analogue Scale at 2, 24, and 48 hours after surgery. Researchers also monitor flap survival and sensory function daily for seven days, noting any complications like hematoma or infection. Other assessments include sedation levels, adverse events such as nausea or dizziness, length of hospital stay, and intraoperative hemodynamics. The study aims to provide insights into which analgesic combination offers better pain control with fewer side effects and improved flap outcomes.

CONDITIONS

Brief Title

Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap Survival in Patients Undergoing Oral Cancer Radical Surgery: A Randomized Controlled Clinical Trial.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with oral malignant tumor
  • Scheduled for oral cancer radical surgery with free flap reconstruction at Sun Yat-sen Memorial Hospital
  • Age between 18 and 70 years
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Use of analgesic medications within two weeks prior to surgery
  • History of diabetes, arteriosclerosis, or peripheral vascular disease
  • Use of hormones, chemotherapy, or immunosuppressants
  • Severe cardiac, pulmonary, hematological, hepatic, or renal diseases
  • Known allergy to the study drugs or their components
  • Unable or unwilling to provide informed consent or comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and first 48 hours postoperatively

Participants undergo oral cancer radical surgery with free flap reconstruction and receive standardized general anesthesia. Postoperative patient-controlled intravenous analgesia (PCIA) containing either Dezocine or Nalbuphine combined with Sufentanil begins immediately after surgery.

Continuous monitoring during surgery and 3 visits at 2, 24, and 48 hours after surgery

Post-operative Follow-up

Duration - 7 days post surgery up to 30 days until discharge

Participants are monitored daily for flap survival, sensory function recovery, and postoperative adverse events. Hospital stay duration is recorded until discharge.

Daily visits from postoperative day 1 to day 7 and discharge visit

Trial Site Locations

Total: 1 location

1

Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

G

Ganglan Fu, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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