Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
NCT Number: NCT05205720
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Hangzhou, Zhejiang, China
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 The intravenous analgesia pump shall be withdrawn after 72 hours of use.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.
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.
Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.
Time frame: 72 hours after surgery
Morphine equivalent
Time frame: Every 24 hours post-surgery for 72 hours
Daily frequency of pump presses
Time frame: 72 hours after surgery
Time frame: After surgery to before discharge, up to 2 months
Time frame: At the end of surgery and 24 hours post-surgery
Laboratory tests of white blood cell count (WBC)
Time frame: At the end of surgery and 24 hours post-surgery
Laboratory tests of C-reactive protein (CRP)
Time frame: At the end of surgery and 24 hours post-surgery
Laboratory tests of erythrocyte sedimentation rate (ESR)
Time frame: At the end of surgery and 24 hours post-surgery
Laboratory tests of interleukin-6 (IL-6)
Time frame: At the end of surgery and 24 hours post-surgery
Laboratory tests of procalcitonin (PCT)
Time frame: 6, 12, 24, 48, 72 hours after surgery
VAS (0 indicates no pain and score 10 indicates the most severe pain)
Time frame: Before and 5、10、20 minutes after CPB
Celiac plexus block (CPB)
Time frame: Before and 5、10、20 minutes after CPB
Celiac plexus block (CPB)
Time frame: Every 12 hours post-surgery for 72 hours
Mean arterial pressure (MAP)
Time frame: Every 12 hours post-surgery for 72 hours
Heart rate (HR)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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