Postoperative Pain
Conditions
Brief summary
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
Interventions
DRUGTegileridine
Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
DRUGSufentanil
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
DRUGPalonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, care providers, and outcomes assessors will be blinded to group allocation. Study drugs will be prepared and labeled by personnel not involved in postoperative care or outcome assessment to maintain blinding.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group for postoperative patient-controlled intravenous analgesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years. * Elective major abdominal surgery as defined above. * Body mass index (BMI) 18-30 kg/m². * American Society of Anesthesiologists (ASA) physical status I to III. * Written informed consent.
Exclusion criteria
* Known hypersensitivity to opioids or any component of the study medications. * Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma. * Known or suspected gastrointestinal obstruction, including paralytic ileus. * Pregnancy or breastfeeding. * Severe hepatic impairment (Child-Pugh class C). * Severe heart failure (NYHA class III-IV) or unstable arrhythmia. * Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness). * History of chronic pain or long-term use of analgesics/analgesic products. * Current use of sedative-hypnotic medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU | From 0 to 24 hours after admission to the PACU | The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting and Movement Pain Intensity | At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU | Resting and movement pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be recorded at 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU. |
| PCIA Demand and Effective Press Counts | Within 48 hours after admission to the PACU. | Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU. |
| Use of Rescue Analgesia | Within 72 hours after admission to the PACU | The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU. |
| Incidence and Severity of PONV | Within 72 hours after admission to the PACU | The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed using a standardized nausea and vomiting assessment scale within 72 hours after admission to the PACU. |
| Time to First Flatus | From admission to the PACU until first passage of flatus, assessed up to 1 week. | Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus. |
| Time to First Bowel Movement | From admission to the PACU until first bowel movement, assessed up to 1 week. | Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement. |
| Time to Resumption of Oral Intake | From admission to the PACU until resumption of oral intake, assessed up to 1 week. | Time to resumption of oral intake will be defined as the time from admission to the PACU to the first postoperative intake of liquids, semi-liquid food, or regular diet. |
| Length of Postoperative Hospital Stay | From admission to the PACU until hospital discharge, assessed up to 30 days. | Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge. |
Contacts
CONTACTJihong Jiang, MD
CONTACTJie Xiao
Outcome results
None listed