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Effect of nalbuphine on relieving pruritus caused by intrathecal morphine analgesia during major laparoscopic surgery: a single-center, randomized, triple-blind, controlled clinical trial

Effect of nalbuphine on relieving pruritus caused by intrathecal morphine analgesia during major laparoscopic surgery: a single-center, randomized, triple-blind, controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108890
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Pruritus

Interventions

Group N:Half an hour before the end of the operation, 4 mg of nalbuphine was given intravenously (diluted to 10 ml with normal saline). The postoperative intravenous PCA analgesia pump formula was hyd
Group C:10 ml of normal saline was given intravenously half an hour before the end of the surgery, and the postoperative intravenous PCA analgesia pump was formulated with hydromorphone.

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (patients must meet the following criteria to be eligible): 1. Aged 18 or older and able to give informed consent (with explanations provided if necessary) 2. Undergoing one or more of the following types of elective laparoscopic or robotic-assisted laparoscopic abdominal surgery: Colorectal surgery Gynecological surgery Urological/renal surgery 3. Estimated operative time = 2 hours (from skin incision to wound closure) 4. Estimated hospital stay = 24 hours (starting at midnight on the day of surgery)

Exclusion criteria

Exclusion criteria: Exclusion Criteria (patients were excluded if any of the following were met): 1. Allergy to study drug; 2. Inability to perform intrathecal injection due to anatomical reasons; 3. Anticipated invasive mechanical ventilation after surgery; 4. American Society of Anesthesiologists (ASA) class IV or higher; 5. Coagulopathy (i.e., INR > 1.3 and/or platelet count < 100 × 10^9/L); 6. Cognitive or language impairment, unable to participate in the study and complete questionnaires; 7. Failure to appropriately and promptly discontinue medications that affect coagulation (except aspirin) before surgery; 8. Infection near the site of anticipated intrathecal injection; 9. Ongoing sepsis; 10. Patients already enrolled in the trial whose postoperative condition necessitates return to the operating room for a new abdominal surgery; 11. Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Itching score;

Secondary

MeasureTime frame
QoR-15 score;pain NRS score;Respiratory depression;Nausea and vomiting score;

Countries

China

Contacts

Public ContactFeng Xia

The First Affiliated Hospital, Sun Yat-sen University

fengxia@mail.sysu.edu.cn+86 20 8733 8779

Outcome results

None listed

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