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Effect of intrathecal hydromorphone combined with transverse abdominal plane block on acute and chronic postoperative pain in the major upper abdominal surgery: a multicenter, randomized controlled study

Effect of intrathecal hydromorphone combined with transverse abdominal plane block on acute and chronic postoperative pain in the major upper abdominal surgery: a multicenter, randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069163
Enrollment
Unknown
Registered
2023-03-08
Start date
2023-03-20
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

major upper abdominal surgery

Interventions

Part1: Intrathecal hydromorphone:The dose of intrathecal hydromorphone will start at 50 µg and be adjusted upwards or downwards. Considering that too small a dose may not provide adequate analgesia, t
Part2- group1: Intrathecal injection of hydromorphone at ED90/ED95 doses.:Based on the data from the first part of the study, we determined the ED90 and ED95 doses of intrathecal hydromorphone, which
Part2- group2: Transversal plane block group :After the induction of general anesthesia, the patient was placed in a supine position. The anesthesiologist performed abdominal disinfection and draping.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. ASA grade I-III; 3. To receive elective upper abdominal surgery under general anesthesia, the operation grade was grade A and the operation duration was >= 2 hours; (Class A operations include radical resection of complex pancreatic cancer, hepatectomy of left and right half of liver tumor, radical resection of bile duct cancer, laparoscopic resection of liver tumor, radical resection of gastric cancer, pancreaticoduodenectomy, etc.); 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Underweight or obese patients (BMI= 30 kg/m^2); 2. There are contraindications for intraspinal manipulation, including patients with coagulopathy (platelet 1.5), puncture site infection, spinal malformation or trauma, and suspected malignant tumor bone metastasis; 3. Patients with chronic pain or chronic opioid use (daily opioid use >=3 months or morphine use >=60mg/d and >=1 month); 4. Allergy to the related drugs in this study; 5. do not agree to the use of a postoperative self-controlled analgesia pump; 6. Patients with language communication disorders, unable to understand preoperative education, research process, and the use of pain relief pump; 7. Participate in other clinical trials within 3 months prior to inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Duration of first need for remedial opioids after surgery;

Secondary

MeasureTime frame
Incidence of moderate and severe postoperative pain;Incidence of postoperative chronic pain;Total opioid consumption;Postoperative rehabilitation index;The NRS score (Numeric Rating Scale) for pain after surgery;

Countries

China

Contacts

Public ContactQian Li

West China Hospital, Sichuan University

hxliqian@foxmail.com+86 189 8060 1635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 20, 2026