Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery

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• Pain, Postoperative 5,093

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 84 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Study arms

• Experimental
  Tegileridine Group

  Participants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.

  Drug: Tegileridine · Drug: Palonosetron

• Active comparator
  Sufentanil Group

  Participants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.

  Drug: Sufentanil · Drug: Palonosetron

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.

Primary outcomes

1. Area Under the Curve of Resting Pain Intensity Within 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.

   Time frame: From 0 to 24 hours after admission to the PACU

Secondary outcomes

1. Resting and Movement Pain Intensity

   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.

   Time frame: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU

2. PCIA Demand and Effective Press Counts

   Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.

   Time frame: Within 48 hours after admission to the PACU.

3. Use of Rescue Analgesia

   The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.

   Time frame: Within 72 hours after admission to the PACU

4. Incidence and Severity of PONV

   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 frame: Within 72 hours after admission to the PACU

5. Time to First Flatus

   Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.

   Time frame: From admission to the PACU until first passage of flatus, assessed up to 1 week.

6. Time to First Bowel Movement

   Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.

   Time frame: From admission to the PACU until first bowel movement, assessed up to 1 week.

7. Time to Resumption of Oral Intake

   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.

   Time frame: From admission to the PACU until resumption of oral intake, assessed up to 1 week.

8. Length of Postoperative Hospital Stay

   Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.

   Time frame: From admission to the PACU until hospital discharge, assessed up to 30 days.

Other outcomes

1. Changes in Inflammatory Biomarkers

   Serum levels of inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha), will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on systemic inflammatory response.

   Time frame: Before surgery and at predefined time points within 72 hours after admission to the PACU

2. Changes in I-FABP

   Serum intestinal fatty acid-binding protein (I-FABP) levels will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on intestinal injury.

   Time frame: Before surgery and at predefined time points within 72 hours after admission to the PACU

Individual participant data

Plan to share: No — Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.