Effects of thoracic epidural anesthesia in patients with acute pancreatitis and early organ failure

ISRCTN ISRCTN13326494
DOI https://doi.org/10.1186/ISRCTN13326494
Sponsor Sir Run Run Shaw Hospital
Funder Sir Run Run Shaw Hospital
Submission date
22/03/2026
Registration date
24/03/2026
Last edited
24/03/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Hong Yu
Principal investigator, Scientific

QinChun Road 3#
Hangzhou
310012
China

+86 13605705907
blueyu000@zju.edu.cn
Dr Xin Yu
Public, Scientific

QinChun Road 3#
Hangzhou
310012
China

+86 13588708514
xinxin_yu@zju.edu.cn
Dr Lu Ke
Scientific

No. 305, Zhongshan East Road, Xuanwu District
Nanjing
210000
China

ORCiD logo 0000-0001-8093-5073
+86 15850768312
kelu@nju.edu.cn
Dr Bao Fu
Public

No. 149, Dalian Road, Huichuan District
Zunyi
563000
China

+86 18798121970
fubao0607@126.com
Dr Ya Liu
Public

No. 215, Heping West Road, Xinhua District
Shijiazhuang
050000
China

+86 15803217957
26901224@hebmu.edu.cn
Dr Xianglin Meng
Public

No. 23 Youzheng Street, Nangang District
Harbin
150000
China

+86 13936683621
mengxianglin@hrbmu.edu.cn
Longxiang Cao
Public

Department of Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, No. 305, Zhongshan East Road, Xuanwu District
Nanjing
210002
China

+86 13270806915
caolongxiang321@126.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleEffects of thoracic epidural anesthesia in patients with acute pancreatitis and early organ failure: a multicenter, open-label, randomized, parallel- controlled trial
Study acronymTEAPAN
Study objectives
Ethics approval(s)

Approved 12/02/2026, Ethics Committee of Sir Run Run Shaw Hospital (QinChun Road 3#, Hangzhou, 310012, China; +86 0571-86006906; -), ref: 2023-869-04

Health condition(s) or problem(s) studiedEffective interventions to improve organ function and prognosis in patients with acute pancreatitis
InterventionRandomization was performed using a stratified block design with randomly permuted block sizes, stratified by center, via a computer-generated program. Patients will be randomized to receive thoracic epidural analgesia for at least 5 days and a maximum of 7 days (intervention group) or conventional analgesic treatment (control group).
Patients assigned to the intervention group will receive TEA as soon as possible after randomization. An epidural catheter was placed in an intervertebral space between the eighth and tenth thoracic vertebrae by a certified anesthesiologist. A test dose of 3 mL of 1% lidocaine was administered to assess the anesthetic level and confirm the efficacy and safety of epidural anesthesia. Upon confirmation, 0.15% ropivacaine 250mL + sufentanil 0.3 μg/mL was administered via continuous infusion at 5-7 mL/h. According to clinical analgesic requirements, a bolus of 2-3 mL was added as necessary.
Patients assigned to the control group will receive conventional analgesic treatment. The analgesic treatment was based on the WHO analgesic ladder, including intravenous administration of nonsteroidal anti-inflammatory drugs (e.g., flurbiprofen) and intravenous administration of opioid analgesics (e.g., tramadol).
Pain was assessed every 4 hours on the day of surgery (within 24 hours). From the second day post-surgery until the day of catheter removal, pain was assessed three times daily (every 8 hours). Pain management goals were similar among both groups: an NRS (Numeric Rating Scale) score of ≤3 in communicative patients with intact consciousness, or a CPOT (Critical-Care Pain Observation Tool) score of ≤2 in non-communicative patients.
Intervention typeProcedure/Surgery
Primary outcome measure(s)
  1. Organ failure-free days (OFFD) to 14 days of enrolment measured using the number of OFFD, defined as the number of days alive without organ failure. Organ failure is defined on individual SOFA-2 score of 2 or more for cardiovascular, respiratory, or renal organ systems; only the final period of OFFD will be counted, at days 1 to 14 after enrolment. Patients discharged from the hospital before 14 days will be considered alive and free from organ failure since the day of discharge. Patients who died before day 14 will be assigned zero OFFD.
Key secondary outcome measure(s)
  1. SIRS-free days to 14 days of enrolment measured using the number of days the patient survived without meeting the SIRS diagnostic criteria at days 1 to 14 after enrolment
  2. The severity-of-disease measured using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score at days 1, 3, 5, and 7 after enrolment
  3. Organ support-free days to 14 days of enrolment measured using the number of days the patient survived without requiring respiratory support, renal replacement therapy, or circulatory support within the 14-day of enrollment at days 1 to 14 after enrolment
  4. Assessment of pain in ICU measured using the Numeric Rating Scale (NRS) and Critical-Care Pain Observation Tool (CPOT) scores at days 1, 3, 5, and 7 after enrolment
  5. Dosage of analgesics used measured using data collected from records on the dosage of analgesics used at days 1 to 7 after enrolment
  6. Subject satisfaction with analgesic treatment measured using a 5-point Likert scale (ratings: not at all satisfied, slightly satisfied, neutral, very satisfied, and extremely satisfied) at days 1 to 5 after enrolment
  7. Incidence of Infected Pancreatic Necrosis (IPN) measured using data collected from records on the incidence of IPN at day 28 after enrolment
  8. Number of interventional drainage or retroperitoneal pancreatic necrosectomy debridement and drainage procedures required measured using data collected from records on the interventional drainage or retroperitoneal pancreatic necrosectomy debridement and drainage procedures required at day 28 after enrolment
  9. Incidence of Deep Vein Thrombosis (DVT) measured using data collected from records on the incidence of DVT at day 28 after enrolment
  10. Incidence of sepsis measured using data collected from records on the incidence of sepsis at day 28 after enrolment
  11. Incidence of gastrointestinal fistula measured using data collected from records on the incidence of gastrointestinal fistula at day 28 after enrolment
  12. Incidence of abdominal bleeding measured using data collected from records on the incidence of abdominal bleeding at day 28 after enrolment
  13. Acute pancreatitis severity measured using data collected from records on the CT Severity Index (CTSI) score at day 28 after enrolment
  14. Intra-abdominal pressure measured using the intravesical method (bladder pressure measurement) at 3-6 hours after treatment and on days 1, 3, 5, and 7 after enrolment
  15. Average caloric/protein intake measured using data collected from records on the average caloric/protein intake at days 1 to 7 after enrolment
  16. Tolerance of enteral nutrition measured using data collected from records on the tolerance of enteral nutrition at days 1 to 7 after enrolment
  17. GI dysfunction measured using the Gastrointestinal Dysfunction Score (GIDS) at days 1 to 7 after enrolment
  18. All-cause mortality measured using data collected from records on all-cause mortality at day 28 after enrolment
  19. Intensive Care Unit (ICU) free-days, defined as the number of days alive and discharge from the ICU measured using data collected from records at day 28 after enrolment
  20. Total cost of this hospitalization measured using data collected from records at from enrolment to discharge
  21. Health-related quality of life measured using European Quality of Life Five-Dimension Five-Level Scale (EQ-5D-5L) at Days 180, 365 after enrolment
  22. Symptoms and quality of life measured using PAN-PROMISE score at days 180 and 365 after enrolment
  23. Recurrence rate of acute pancreatitis measured using data collected from records on the recurrence rate of acute pancreatitis at day 365 after enrolment
  24. Incidence of chronic pancreatitis measured using data collected from records on the incidence of chronic pancreatitis at day 365 after enrolment
  25. Incidence of Post-pancreatitis diabetes mellitus measured using data collected from records on the incidence of Post-pancreatitis diabetes mellitus at day 365 after enrolment
  26. Incidence of pancreatic exocrine insufficiency measured using data collected from records on the incidence of pancreatic exocrine insufficiency at day 365 after enrolment
Completion date30/04/2031

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit70 Years
SexAll
Target sample size at registration244
Key inclusion criteria1. Aged between 18 and 70 years
2. Admitted to the hospital within 72 h of the onset of abdominal pain, diagnosed with acute pancreatitis
3. With organ failure as defined by the sequential organ failure assessment-2(SOFA-2)score for respiration, renal and cardiovascular systems
4. Voluntary participation; signed informed consent required
Key exclusion criteria1. Pregnant or lactating women, or those planning pregnancy within 6 months
2. Acute pancreatitis associated with chronic pancreatitis or pancreatic neoplasms
3. Patients who have undergone retroperitoneal percutaneous drainage
4. Post-cardiopulmonary resuscitation status with unresolved neurological dysfunction
5. Patients with a history of severe primary cardiovascular, respiratory, renal, hepatic, hematological, malignant tumor, or immune diseases
6. Patients with contraindications to TEA: those who are allergic to local anesthetics; those accompanied by severe systemic infection, infection at the puncture site, epidural abscess, or central nervous system infection; those with central nervous system diseases such as spinal cord lesions, spinal nerve root lesions, or intracranial hypertension; patients in shock; those with anatomical variations or a history of back surgery related to the epidural space, making TEA impossible; those with coagulation disorders or those who have not met the required withdrawal time for anticoagulant or antiplatelet medications; those with mental illness, severe neurosis, or other conditions that make cooperation impossible.
7. Participation in other interventional clinical studies within the past 3 months
8. Other conditions deemed unsuitable for inclusion by the investigator
Date of first enrolment01/04/2026
Date of final enrolment01/04/2031

Locations

Countries of recruitment

  • China

Study participating centres

Sir Run Run Shaw Hospital of Zhejiang University, Hangzhou, China
QinChun Road 3#
Hangzhou
310012
China
Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
No. 305, Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China
Nanjing
210000
China
The Affiliated Hospital of Zunyi Medical University
No. 149, Dalian Road, Huichuan District, Zunyi City, Guizhou Province, China
Zunyi
563000
China
The Second Hospital of Hebei Medical University
No. 215, Heping West Road, Xinhua District, Shijiazhuang City, Hebei Province, China
Shijiazhuang
050000
China
The First Affiliated Hospital of Harbin Medical University
No. 23 Youzheng Street, Nangang District, Harbin City, Heilongjiang Province, China,150086.
Harbin
150000
China

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan

Editorial Notes

23/03/2026: Study’s existence confirmed by the Ethics Committee Approval Letter of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, China.

BMC - Part of Springer Nature Springer Nature