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Clinical Study on the Analgesic Efficacy of Nalbuphine Combined with Ropivacaine in Ultrasound-Guided Caudal Block for Perioperative Management of Perianal Surgery

Clinical Study on the Analgesic Efficacy of Nalbuphine Combined with Ropivacaine in Ultrasound-Guided Caudal Block for Perioperative Management of Perianal Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123588
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Sacrospinal anesthesia for perianal surgery

Interventions

Low-dose experimental group:For sacral block, use 3 mg of nalbuphine plus 20 ml of 0.375% ropivacaine, for a total of 20 ml.
Medium Dose Experimental Group:For sacral block, use 5mg of nalbuphine plus 20 ml of 0.375% ropivacaine, for a total of 20 ml.
High-dose experimental group:For sacral block, use 10 mg of nalbuphine plus 20 ml of 0.375% ropivacaine, for a total of 20 ml.
Control group:20 ml of 0.375% ropivacaine was used for sacral block

Sponsors

Yongkang First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18–65 years old, regardless of gender. 2. ASA classification: Grades I–II. 3. BMI < 30 kg/m^2. 4. Surgery duration <= 2 hours. 5. Underlying diseases are well-controlled, with no allergy to anesthetics. 6. Informed consent form has been signed. 7. Procedures involving the perianal area, primarily including external dissection and internal ligation for hemorrhoids, resection of low-grade anal fistulas, incision and drainage of low-grade perianal abscesses, and lateral incision for anal fissures.

Exclusion criteria

Exclusion criteria: 1. Infection at the puncture site; 2. Blood-related disorders; 3. Malignant tumors; 4. Mental abnormalities preventing effective communication; 5. Disorders of the central or peripheral nervous system; 6. Co-existing conditions affecting other surgical sites; 7. Long-term use of pain medications; 8. Need for a second surgery within 48 hours after the initial operation.

Design outcomes

Primary

MeasureTime frame
Resting NRS pain scores at different time points after surgery (3h, 6h, 12h, 24h post-surgery);

Secondary

MeasureTime frame
Onset time of sensory block;Intraoperative hemodynamic changes;Exercise NRS pain score at the same time point after surgery;Proportion of patients who first requested analgesic relief and those who required emergency analgesics;Incidence of adverse reactions;NRS score for the first independent walk after surgery and proportion of patients who were able to walk with a NRS pain score = 4;

Countries

China

Contacts

Public ContactZhu Luyao

Yongkang First People's Hospital

1419630492@qq.com+86 183 5897 3998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026