Oral CancerNCT07401641
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.
A study testing Dezocine and Sufentanil combination and Nalbuphine and Sufentanil combination in people with Oral Cancer and Postoperative Pain Management, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Cancer, Postoperative Pain Management, Free Tissue Flaps
- What is being tested?
- Dezocine and Sufentanil combination and Nalbuphine and Sufentanil combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
Guangzhou, Guangdong, 510000
Ganglan Fu, Dr, 86+13570275074, fugangl@mail.sysu.edu.cn
About this study
Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Their comparative effects on analgesia, complications, and flap survival in oral cancer surgery are unknown.
Objective: To compare the efficacy of dezocine versus nalbuphine, both combined with sufentanil, for postoperative analgesia, and to evaluate their impact on postoperative complications and free flap survival/function in patients undergoing oral cancer radical surgery with flap reconstruction.
Read more
Methods: This is a prospective, randomized, double-blind, controlled trial. Sixty eligible patients (aged 18-70, ASA I-III) will be randomly assigned (1:1) to receive postoperative patient-controlled intravenous analgesia (PCIA) with either Sufentanil + Dezocine or Sufentanil + Nalbuphine. The primary outcome is pain intensity assessed by the Visual Analogue Scale (VAS) at 2, 24, and 48 hours postoperatively. Secondary outcomes include flap survival status, sensory function recovery, incidence of adverse events (e.g., nausea, vomiting), and hospitalization duration.
Potential Impact: This study may identify a superior postoperative analgesic regimen that provides effective pain relief while potentially improving flap outcomes and minimizing side effects for oral cancer patients.
Read the detailed description
Design: Single-center, prospective, randomized, double-blind, active-controlled, parallel-group trial.
Interventions:
Group D: Sufentanil (1.0 µg/kg) + Dezocine (0.4 mg/kg) diluted to 150ml with normal saline for PCIA (no basal infusion, bolus 2.5 ml, lockout 15 min).
Group N: Sufentanil (1.0 µg/kg) + Nalbuphine (1.0 mg/kg) diluted to 150ml with normal saline for PCIA (parameters identical to Group D).
Standardized general anesthesia protocol for both groups.
Primary Outcome: Postoperative pain scores (VAS, 0-10) at rest at 2, 24, and 48 hours after surgery.
Secondary Outcomes:
Flap survival status (e.g., hematoma, dehiscence, necrosis, infection) on postoperative days 1-7.
Flap sensory function: static/dynamic two-point discrimination and Semmes-Weinstein monofilament test on days 1-7.
Incidence of postoperative adverse events (nausea, vomiting, pruritus, dizziness, sedation).
Postoperative hospital stay duration.
Ramsay sedation scores at 2, 24, and 48 hours.
Intraoperative hemodynamics and blood loss.
Sample Size: 60 patients (30 per group). The calculation is based on a pilot study detecting a difference in 24h VAS scores (1.52 vs 2.35, SD=0.89) with 90% power and α=0.05, accounting for a 20% dropout rate.
- Being tested
- Dezocine and Sufentanil combination, Nalbuphine and Sufentanil combination
- Keywords
- Dezocine, Nalbuphine, Oral Cancer Surgery, Free Flap Reconstruction, Postoperative Analgesia, Randomized Controlled Trial, Flap Survival
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dezocine and Sufentanil combinationDrug
Postoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Dezocine (at a dose of 0.4 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump is programmed with no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery.
Nalbuphine and Sufentanil combinationDrug
Postoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Nalbuphine (at a dose of 1.0 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump settings are identical to the comparator regimen: no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dezocine + Sufentanil | Experimental | Participants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Dezocine (0.4 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump is set with no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery. Receives: Drug: Dezocine and Sufentanil combination |
| Nalbuphine + Sufentani | Active comparator | Participants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Nalbuphine (1.0 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump settings are identical to the experimental group: no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery. Receives: Drug: Nalbuphine and Sufentanil combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity assessed at rest using the Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Patients mark their current pain level on the line.
Measured: At 2 hours, 24 hours, and 48 hours after surgery.
Secondary outcomes (7)
Incidence of Flap Complications
The occurrence of complications in the transferred free flap, assessed daily by clinical examination. Complications include hematoma, wound dehiscence, skin necrosis, and infection.
Measured: Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Two-Point Discrimination (2PD)
Sensory function recovery of the flap assessed using a Disk-Criminator to measure static and dynamic two-point discrimination (2PD). Lower values indicate better sensory discrimination.
Measured: Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Light Touch Threshold
Sensory function recovery of the flap assessed using Semmes-Weinstein monofilaments. The test determines the minimal force (g/mm²) required for the patient to perceive light touch, with lower values indicating better sensitivity.
Measured: Daily from postoperative day 1 to day 7.
Incidence of Postoperative Adverse Events
The frequency of common postoperative adverse effects, including nausea, vomiting, pruritus (itching), dizziness, and somnolence (drowsiness), as recorded in patient charts and through direct questioning.
Measured: From the end of surgery until 48 hours postoperatively.
Ramsay Sedation Score
Level of sedation assessed using the Ramsay Sedation Scale (scores 1-6, where 1=anxious/agitated, 2=cooperative/oriented/tranquil, 3=responsive to commands only, 4-6=asleep with varying responses to stimulus).
Measured: At 2 hours, 24 hours, and 48 hours after surgery.
Postoperative Hospital Stay Duration
The total length of hospitalization (in days) from the day of surgery until the day of discharge, meeting standard discharge criteria.
Measured: From the day of surgery until the day of discharge (assessed up to 30 days).
Intraoperative Hemodynamic Stability
Measurement of intraoperative stability, including heart rate (beats per minute), blood pressure (mmHg), and peripheral oxygen saturation (SpO2, %). Data points are recorded every 5 minutes.
Measured: From anesthesia induction until the end of surgery (intraoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401641
- Sponsor's protocol ID
- SYSKY-2025-417-01
- Status last verified
- Dec 2025
- First submitted
- 19 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07401641
- Acronym / sponsor ID
- SYSKY-2025-417-01
- Keywords
- Dezocine, Nalbuphine, Oral Cancer Surgery, Free Flap Reconstruction, Postoperative Analgesia, Randomized Controlled Trial, Flap Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Their comparative effects on analgesia, complications, and flap survival in oral cancer surgery are unknown.
Objective: To compare the efficacy of dezocine versus nalbuphine, both combined with sufentanil, for postoperative analgesia, and to evaluate their impact on postoperative complications and free flap survival/function in patients undergoing oral cancer radical surgery with flap reconstruction.
Methods: This is a prospective, randomized, double-blind, controlled trial. Sixty eligible patients (aged 18-70, ASA I-III) will be randomly assigned (1:1) to receive postoperative patient-controlled intravenous analgesia (PCIA) with either Sufentanil + Dezocine or Sufentanil + Nalbuphine. The primary outcome is pain intensity assessed by the Visual Analogue Scale (VAS) at 2, 24, and 48 hours postoperatively. Secondary outcomes include flap survival status, sensory function recovery, incidence of adverse events (e.g., nausea, vomiting), and hospitalization duration.
Potential Impact: This study may identify a superior postoperative analgesic regimen that provides effective pain relief while potentially improving flap outcomes and minimizing side effects for oral cancer patients.
Detailed description
Design: Single-center, prospective, randomized, double-blind, active-controlled, parallel-group trial.
Interventions:
Group D: Sufentanil (1.0 µg/kg) + Dezocine (0.4 mg/kg) diluted to 150ml with normal saline for PCIA (no basal infusion, bolus 2.5 ml, lockout 15 min).
Group N: Sufentanil (1.0 µg/kg) + Nalbuphine (1.0 mg/kg) diluted to 150ml with normal saline for PCIA (parameters identical to Group D).
Standardized general anesthesia protocol for both groups.
Primary Outcome: Postoperative pain scores (VAS, 0-10) at rest at 2, 24, and 48 hours after surgery.
Secondary Outcomes:
Flap survival status (e.g., hematoma, dehiscence, necrosis, infection) on postoperative days 1-7.
Flap sensory function: static/dynamic two-point discrimination and Semmes-Weinstein monofilament test on days 1-7.
Incidence of postoperative adverse events (nausea, vomiting, pruritus, dizziness, sedation).
Postoperative hospital stay duration.
Ramsay sedation scores at 2, 24, and 48 hours.
Intraoperative hemodynamics and blood loss.
Sample Size: 60 patients (30 per group). The calculation is based on a pilot study detecting a difference in 24h VAS scores (1.52 vs 2.35, SD=0.89) with 90% power and α=0.05, accounting for a 20% dropout rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dezocine + Sufentanil | Experimental | Drug: Dezocine and Sufentanil combinationParticipants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Dezocine (0.4 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump is set with no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery. |
| Nalbuphine + Sufentani | Active comparator | Drug: Nalbuphine and Sufentanil combinationParticipants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Nalbuphine (1.0 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump settings are identical to the experimental group: no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Sign informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dezocine and Sufentanil combinationPostoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Dezocine (at a dose of 0.4 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump is programmed with no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery. | Drug | Dezocine + Sufentanil |
| Nalbuphine and Sufentanil combinationPostoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Nalbuphine (at a dose of 1.0 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump settings are identical to the comparator regimen: no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery. | Drug | Nalbuphine + Sufentani |
Primary outcome
Postoperative Pain Intensity
Time frame: At 2 hours, 24 hours, and 48 hours after surgery.
Pain intensity assessed at rest using the Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Patients mark their current pain level on the line.
7 secondary outcomes
Incidence of Flap Complications
Time frame: Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Two-Point Discrimination (2PD)
Time frame: Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Light Touch Threshold
Time frame: Daily from postoperative day 1 to day 7.
Incidence of Postoperative Adverse Events
Time frame: From the end of surgery until 48 hours postoperatively.
Ramsay Sedation Score
Time frame: At 2 hours, 24 hours, and 48 hours after surgery.
Postoperative Hospital Stay Duration
Time frame: From the day of surgery until the day of discharge (assessed up to 30 days).
Intraoperative Hemodynamic Stability
Time frame: From anesthesia induction until the end of surgery (intraoperative period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dezocine and Sufentanil combination and Nalbuphine and Sufentanil combination in people with Oral Cancer and Postoperative Pain Management, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ganglan Fu, M.D. (86+13570275074, ganglan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: At 2 hours, 24 hours, and 48 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.