Trigonelline Plus Sufentanil for Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
NCT07914946, Not applicable, Completed, Hainan Medical College
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Trigonelline Plus Sufentanil for Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial | ClinicalTrials.gov |
| NCT number | NCT07914946 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 165 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Hainan Medical College | ClinicalTrials.gov |
| Conditions | Pain, Postoperative, Postoperative Nausea and Vomiting | ClinicalTrials.gov |
| Interventions | Sufentanil, Trigonelline | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) Pain Score at Rest and During Movement | From surgery end (Time 0) through 48 hours postoperatively, with assessments at 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after arrival in the Post-Anesthesia Care Unit (PACU). Primary endpoint assessment at 24 hours. | The Visual Analog Scale (VAS) is used to measure postoperative pain intensity. Participants are asked to mark their current pain level on a 100-millimeter horizontal line, where 0 millimeters represents "no pain" and 100 millimeters represents "the worst imaginable pain." Pain scores are assessed under two conditions: (1) at rest, while the participant is lying quietly in bed; and (2) during movement, specifically during coughing or turning over in bed. Assessments are performed at five time points after surgery: 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours. The primary efficacy endpoint is the VAS pain score at 24 hours after surgery during movement, which will be compared among the three study arms (Sufentanil Monotherapy, Trigonelline Monotherapy, and Combination Therapy). All assessments are conducted by trained research staff who are blinded to group assignment to the extent feasible. | ClinicalTrials.gov |
| Secondary | Ramsay Sedation Score | At 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery (up to 48 hours postoperatively) | The Ramsay Sedation Score is used to assess the level of sedation in participants after surgery. The scoring criteria are as follows: 1 = anxious, agitated, or restless; 2 = cooperative, oriented, and tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud auditory stimulus; 5 = sluggish response to light glabellar tap or loud auditory stimulus; 6 = no response to stimuli. Assessments are performed at 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery by trained research staff concurrently with pain assessments. | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) | Within 48 hours after surgery (from end of surgery through 48 hours postoperatively) | The occurrence of postoperative nausea and vomiting (PONV) will be recorded within 48 hours after surgery. Nausea is defined as the subjective sensation of an urge to vomit. Vomiting is defined as the forceful expulsion of gastric contents through the mouth. Severity is graded as: mild (no treatment required), moderate (requires pharmacological antiemetic treatment such as ondansetron), and severe (recurrent episodes despite antiemetic therapy). The time of first onset, number of episodes, and need for antiemetic treatment will be documented. This outcome is used to evaluate differences in gastrointestinal side effects among the three analgesic regimens. | ClinicalTrials.gov |
| Secondary | Incidence of Other Adverse Events | Within 48 hours after surgery (from end of surgery through 48 hours postoperatively) | Adverse events other than nausea and vomiting will be observed and recorded within 48 hours after surgery. These include: (1) dizziness or vertigo; (2) pruritus (skin itching); (3) chills or shivering; (4) constipation or abdominal distension; (5) respiratory depression, defined as peripheral oxygen saturation (SpO2) below 92%, respiratory rate below 8 breaths per minute, or difficulty arousing the participant. For each adverse event, the following will be documented: presence or absence, severity (mild/moderate/severe), whether intervention is required, and the assessed causal relationship to the study medication. | ClinicalTrials.gov |
| Secondary | Patient-Controlled Intravenous Analgesia (PCIA) Pump Utilization Data | From PCIA pump connection at end of surgery through 48 hours postoperatively | Data on patient-controlled intravenous analgesia (PCIA) pump utilization will be recorded, including: (1) Total number of button presses: the total number of times the participant presses the demand button during the observation period; (2) Number of effective (delivered) presses: the number of presses that result in actual drug delivery (i.e., presses that occur after the lockout interval has elapsed). Pump utilization data are read from the PCIA pump's internal memory and recorded on the case report form. Comparison of pump utilization among the three groups provides an indirect measure of the analgesic efficacy and drug consumption of each regimen. | ClinicalTrials.gov |
| Secondary | Rescue Analgesia Requirement | From ward admission through 48 hours after surgery | Rescue analgesia use and its details will be recorded. When a participant reports a Visual Analog Scale (VAS) pain score of 4 or higher at rest while on the ward, a single intravenous bolus of flurbiprofen axetil 50 mg will be administered as rescue analgesia. A maximum of two rescue doses (total not exceeding 100 mg) may be given within any 24-hour period. The following information will be documented: (1) whether rescue analgesia was required (yes/no); (2) time to first rescue analgesia (hours from end of surgery); (3) total number of rescue doses and cumulative dose administered; (4) VAS pain score before and after rescue analgesia. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)