The effect of tegileridine fumarate on pain scores in patients undergoing laparoscopic total hysterectomy for postoperative pain management

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116006

Enrollment

Unknown

Registered

2026-01-04

Start date

2026-01-12

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperation pain

Interventions

Tegileridine group:Tegileridine fumarate loading dose: 1 mg (5 ml)

5 mg is diluted with 0.9% normal saline to 100 ml. PCIA self-administration dose: 1 ml, lockout time: 10 minutes.

Sufentanil group:Sufentanil loading dose: 10 µg (5 ml)

120 µg is diluted with 0.9% normal saline to 100 ml. PCIA self-administration dose: 1 ml, lockout time: 10 minutes.

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 65 years old; 2.Undergoing laparoscopic total hysterectomy; 3.American Society of Anesthesiologists score (ASA) I-III; 4.Body mass index 18-30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1.Refuse to participate in this study; 2.Undergo emergency surgery; 3.Have acute or severe bronchial asthma; 4.Have known or suspected gastrointestinal obstruction; 5.Have a history of chronic pain, or regularly use opioid drugs; 6.Have a history of alcohol abuse; 7.Have a history of abdominal surgery within the past six months; 8.Unable to understand the scoring scale related to the study; 9.Allergic to any drugs in this study.

Design outcomes

Primary

Measure	Time frame
The cumulative area under the curve (AUC) of the NRS pain score during rest within 48 hours after the surgery (after tube removal);	—

Secondary

Measure	Time frame
The AUC values of the pain NRS scores at rest and during turning over within 0, 12, 24, and 36 hours after the operation, and the AUC value of the pain NRS score during turning over at 48 hours after the operation;The incidence and severity of postoperative nausea and vomiting (PONV) within 0, 12, 24, 36, and 48 hours after the operation;The incidence of dizziness at 0, 12, 24, 36 and 48 hours after the operation;The time of the first rectal gas expulsion after the operation;Postoperative ward analgesic rescue measures (first rescue analgesia time, number of rescue analgesia sessions, dosage of rescue analgesic drugs);QoR-15 Questionnaire Scale Score;	—

Measure

Time frame

The AUC values of the pain NRS scores at rest and during turning over within 0, 12, 24, and 36 hours after the operation, and the AUC value of the pain NRS score during turning over at 48 hours after the operation;The incidence and severity of postoperative nausea and vomiting (PONV) within 0, 12, 24, 36, and 48 hours after the operation;The incidence of dizziness at 0, 12, 24, 36 and 48 hours after the operation;The time of the first rectal gas expulsion after the operation;Postoperative ward analgesic rescue measures (first rescue analgesia time, number of rescue analgesia sessions, dosage of rescue analgesic drugs);QoR-15 Questionnaire Scale Score;

—

Countries

China

Contacts

Public ContactYulan Wang

The First Affiliated Hospital of Soochow University

wangyulan3665@suda.edu.cn+86 138 6257 1452

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026