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NCT Number: NCT05205720

Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery

This subject intends to explore the value of intraoperative celiac plexus block in postoperative acute pain management and its promoting effect on patients' rapid recovery during Whipple surgery through a randomized controlled trial.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

About this study

This study is a single center, randomized, single-blind controlled study. After calculating the sample size, 66 subjects would be randomly assigned to nerve block group (NB group: local anesthetic injection at the target position) and blank control group (GC group: no celiac plexus block) according to the ratio of 1:1, in order to evaluate the effectiveness and safety of celiac plexus block (CPB) as a part of multimodal analgesia for postoperative pain management.

Anesthesia protocol: the standard anesthesia protocol for open Whipple surgery in our hospital was adopted.

Postoperative analgesia plan: before abdominal closure at the end of operation, The surgeon was instructed to perform a single celiac plexus block (CPB) under direct vision. Ropivacaine was injected into the target nerve in NB group, but no injection in GC group. After the operation, the anesthesiologist used ropivacaine to perform ultrasound-guided abdominal wall nerve block. When leaving the operating room, connect intravenous analgesia pump. Patients with subjective pain score of 3 or above can press. If the analgesia is insufficient, intravenous injection of dezocine can be added temporarily. The intravenous analgesia pump shall be withdrawn after 72 hours of use. If the analgesia pump is used up and is still needed, the anesthesiologist can evaluate and add medicine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18years;
  • received open Whipple surgery.

Exclusion criteria

  • patients unable to cooperate with evaluations;
  • patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;
  • non-standard surgical procedures, planned postoperative ICU admission;
  • American Society of Anesthesiologists (ASA) classification of 4 or 5.

Withdrawal criteria:

Patients who underwent unplanned surgeries, required reintubation or a second surgery, received ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.

Treatment and study plan

Celiac Plexus Block

Procedure

The surgeon is instructed to perform a single celiac plexus block under direct vision. 10ml 0.5% ropivacaine is injected into the nerve in both sides.

Ropivacaine

Drug

Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.

Primary outcomes

  1. Opioid consumption

    Time frame: 72 hours after surgery

    Morphine equivalent

Secondary outcomes

  1. Press of the analgesic pump

    Time frame: Every 24 hours post-surgery for 72 hours

    Daily frequency of pump presses

  2. Time to first flatus

    Time frame: 72 hours after surgery

  3. Length of postoperative hospitalization

    Time frame: After surgery to before discharge, up to 2 months

  4. White blood cell count

    Time frame: At the end of surgery and 24 hours post-surgery

    Laboratory tests of white blood cell count (WBC)

  5. C-reactive protein

    Time frame: At the end of surgery and 24 hours post-surgery

    Laboratory tests of C-reactive protein (CRP)

  6. Erythrocyte sedimentation rate

    Time frame: At the end of surgery and 24 hours post-surgery

    Laboratory tests of erythrocyte sedimentation rate (ESR)

  7. Interleukin-6

    Time frame: At the end of surgery and 24 hours post-surgery

    Laboratory tests of interleukin-6 (IL-6)

  8. Procalcitonin

    Time frame: At the end of surgery and 24 hours post-surgery

    Laboratory tests of procalcitonin (PCT)

  9. Pain scores

    Time frame: 6, 12, 24, 48, 72 hours after surgery

    VAS (0 indicates no pain and score 10 indicates the most severe pain)

  10. Cardiac index changes during celiac plexus block

    Time frame: Before and 5、10、20 minutes after CPB

    Celiac plexus block (CPB)

  11. Systemic vascular resistance index changes during celiac plexus block

    Time frame: Before and 5、10、20 minutes after CPB

    Celiac plexus block (CPB)

  12. Postoperative mean arterial pressure

    Time frame: Every 12 hours post-surgery for 72 hours

    Mean arterial pressure (MAP)

  13. Postoperative heart rate

    Time frame: Every 12 hours post-surgery for 72 hours

    Heart rate (HR)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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