SurgeryNCT07361822
Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery
A study testing Fixed-rate basal infusion mode and Variable-rate feedback infusion mode in people with Surgery and Pain Management, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery, Pain Management, Opioid Consumption
- What is being tested?
- Fixed-rate basal infusion mode and Variable-rate feedback infusion mode
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Dec 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 to 65 years;
- American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
- Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracic, abdominal, spinal, orthopaedic, and cranial procedures performed using either minimally invasive or open approaches.
Who cannot join
- Allergy to PCA medications;
- Presence of chronic pain syndromes;
- Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.
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
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing
Fang Luo, 13611326978, 13611326978@163.com
About this study
Official title: Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)
Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.
Read the detailed description
Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 80%, which impedes recovery and increases complication risks. Although opioids serve as first-line analgesics, excessive use causes numerous adverse reactions. The traditional fixed-rate Patient-Controlled Analgesia (PCA) mode fails to adapt to dynamic postoperative pain variations. This study will compare different PCA optimization strategies, hypothesizing that these approaches can reduce opioid dosage, enhance analgesic effectiveness, and minimize adverse reactions. The research aims to provide evidence-based foundations for postoperative analgesia, promoting individualized and intelligent pain management systems that better serve patient needs throughout recovery.
- Being tested
- Fixed-rate basal infusion mode, Variable-rate feedback infusion mode
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-rate basal infusion modeProcedure or surgery
All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h.
Variable-rate feedback infusion modeProcedure or surgery
All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In variable-rate feedback infusion mode group, a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h, which increased to 2.5 mL/h, was used whenever the demand dose was administered within lock out interval. The background infusion rate automatically decreased by 0.5 mL/h when the bolus button was not pressed for 1 hour. The background infusion rate was limited to a maximum of 12.0 mL/h and a minimum of 1 mL/h. The specific variable-rate feedback infusion mode setting was based on previous research, and the opinions of manufacturers and researchers to ensure patient safety and to provide effective analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-rate basal infusion mode group | Active comparator | Not described Receives: Procedure: Fixed-rate basal infusion mode |
| Variable-rate feedback infusion mode group | Experimental | Not described Receives: Procedure: Variable-rate feedback infusion mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative opioid consumption
The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics.
Measured: at 48 hours postoperatively
Secondary outcomes (9)
Resting and movement pain score was assessed by NRS
NRS ranges from 0 to 10, with the highest score indicating the worst pain.
Measured: At 1, 6, 12, 24, and 48 hours postoperatively
Cumulative PCA volume consumption
Measured: Within the first 48 hours postoperatively
Number of additional rescue analgesics
Measured: within 48 hours postoperatively
Dosage of additional rescue analgesics
Measured: within 48 hours postoperatively
Postoperative quality of recovery
Postoperative quality of recovery was assessed through the Postoperative Quality of Recovery-15 questionnaire 1 day after surgery. It consists of six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive and overall patient perspective). The score ranges from 0 to 150, with higher score indicating a better quality of postoperative recovery.
Measured: At 24 hours postoperatively
Quality of sleep
Quality of sleep was evaluated on postoperative days 1, 2 and 3 using the Medical Outcomes Study Sleep Scale (MOS). MOS is questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).
Measured: At 24, and 48 hours postoperatively
The level of sedation and agitation
The level of sedation and agitation was assessed using the Richmond Agitation and Sedation Scale, which ranges from +4 (combative agitation) to -5 (deep sedation), with a score of 0 indicating an alert and calm state.
Measured: within 48 hours postoperatively
The degree of nausea and vomiting
The degree of nausea and vomiting, a score from 0 to 10 was given. A score of 0 was given if the patient had no nausea or vomiting, and a score 10 was given if the patient had severe nausea and vomiting.
Measured: At 12, 24, and 48 hours postoperatively
The patient's satisfaction with PCA
The patient's satisfaction with PCA during 2 days postoperatively was assessed according to the following scale: 1, very satisfactory; 2, satisfactory; 3, neutral; 4, unsatisfactory; 5; very unsatisfactory.
Measured: At 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Dec 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University, Youjiang Medical College for Nationalities
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361822
- Sponsor's protocol ID
- KY2025-387-02-1
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Publications
Xing Y, Liu M, Sun Y, Mao X, Li J, Zhang Z, Sun H, Luo F. Comparison of cumulative opioid consumption between variable-rate feedback infusion and fixed-rate basal infusion modes of intravenous patient-controlled analgesia following mixed surgery: protocol for a prospective randomised controlled trial. BMJ Open. 2026 Aug 28;16(8):e117278. doi: 10.1136/bmjopen-2026-117278.
PubMed 42665353
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)
- ClinicalTrials.gov ID
- NCT07361822
- Acronym / sponsor ID
- KY2025-387-02-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,170 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University, Youjiang Medical College for Nationalities
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Jan 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.
Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.
Detailed description
Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 80%, which impedes recovery and increases complication risks. Although opioids serve as first-line analgesics, excessive use causes numerous adverse reactions. The traditional fixed-rate Patient-Controlled Analgesia (PCA) mode fails to adapt to dynamic postoperative pain variations. This study will compare different PCA optimization strategies, hypothesizing that these approaches can reduce opioid dosage, enhance analgesic effectiveness, and minimize adverse reactions. The research aims to provide evidence-based foundations for postoperative analgesia, promoting individualized and intelligent pain management systems that better serve patient needs throughout recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-rate basal infusion mode group | Active comparator | Procedure: Fixed-rate basal infusion mode |
| Variable-rate feedback infusion mode group | Experimental | Procedure: Variable-rate feedback infusion mode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 18 to 65 years;
- American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
- Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracic, abdominal, spinal, orthopaedic, and cranial procedures performed using either minimally invasive or open approaches.
Key exclusion criteria (3 listed)
- Allergy to PCA medications;
- Presence of chronic pain syndromes;
- Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.
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 |
|---|---|---|
| Fixed-rate basal infusion modeAll participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h. | Procedure or surgery | Fixed-rate basal infusion mode group |
| Variable-rate feedback infusion modeAll participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In variable-rate feedback infusion mode group, a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h, which increased to 2.5 mL/h, was used whenever the demand dose was administered within lock out interval. The background infusion rate automatically decreased by 0.5 mL/h when the bolus button was not pressed for 1 hour. The background infusion rate was limited to a maximum of 12.0 mL/h and a minimum of 1 mL/h. The specific variable-rate feedback infusion mode setting was based on previous research, and the opinions of manufacturers and researchers to ensure patient safety and to provide effective analgesia. | Procedure or surgery | Variable-rate feedback infusion mode group |
Primary outcome
Total cumulative opioid consumption
Time frame: at 48 hours postoperatively
The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics.
9 secondary outcomes
Resting and movement pain score was assessed by NRS
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
Cumulative PCA volume consumption
Time frame: Within the first 48 hours postoperatively
Number of additional rescue analgesics
Time frame: within 48 hours postoperatively
Dosage of additional rescue analgesics
Time frame: within 48 hours postoperatively
Postoperative quality of recovery
Time frame: At 24 hours postoperatively
Quality of sleep
Time frame: At 24, and 48 hours postoperatively
The level of sedation and agitation
Time frame: within 48 hours postoperatively
The degree of nausea and vomiting
Time frame: At 12, 24, and 48 hours postoperatively
The patient's satisfaction with PCA
Time frame: At 48 hours postoperatively
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 12 Jun 2026.
- Derived from this study: PubMed 42665353Xing Y, Liu M, Sun Y, Mao X, Li J, Zhang Z, Sun H, Luo F. Comparison of cumulative opioid consumption between variable-rate feedback infusion and fixed-rate basal infusion modes of intravenous patient-controlled analgesia following mixed surgery: protocol for a prospective randomised controlled trial. BMJ Open. 2026 Aug 28;16(8):e117278. doi: 10.1136/bmjopen-2026-117278.
- Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018;22(5):35.Link provided by the sponsor.
- Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37.Link provided by the sponsor.
- Jung KT, So KY, Kim SU, Kim SH. The Optimizing Background Infusion Mode Decreases Intravenous Patient-Controlled Analgesic Volume and Opioid Consumption Compared to Fixed-Rate Background Infusion in Patients Undergoing Laparoscopic Cholecystectomy: A ProLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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 Fixed-rate basal infusion mode and Variable-rate feedback infusion mode in people with Surgery and Pain Management, run by Beijing Tiantan Hospital 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 3 inclusion and 3 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 12 Jun 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 Fang Luo (13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative opioid consumption (time frame: at 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07361822, which also lists 1 linked publication.
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 12 Jun 2026.