Clinical trial NCT05205720: Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
Official title: Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Nerve Block
Keywords: celiac plexus block
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 The intravenous analgesia pump shall be withdrawn after 72 hours of use.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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18years;
2. received open Whipple surgery.

Exclusion Criteria:

1. patients unable to cooperate with evaluations;
2. patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;
3. non-standard surgical procedures, planned postoperative ICU admission;
4. 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.

Primary outcomes:
measure: Opioid consumption
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Press of the analgesic pump
timeFrame: Every 24 hours post-surgery for 72 hours
measure: Time to first flatus
timeFrame: 72 hours after surgery
measure: Length of postoperative hospitalization
timeFrame: After surgery to before discharge, up to 2 months
measure: White blood cell count
timeFrame: At the end of surgery and 24 hours post-surgery
measure: C-reactive protein
timeFrame: At the end of surgery and 24 hours post-surgery
measure: Erythrocyte sedimentation rate
timeFrame: At the end of surgery and 24 hours post-surgery
measure: Interleukin-6
timeFrame: At the end of surgery and 24 hours post-surgery
measure: Procalcitonin
timeFrame: At the end of surgery and 24 hours post-surgery
measure: Pain scores
timeFrame: 6, 12, 24, 48, 72 hours after surgery
measure: Cardiac index changes during celiac plexus block
timeFrame: Before and 5、10、20 minutes after CPB
measure: Systemic vascular resistance index changes during celiac plexus block
timeFrame: Before and 5、10、20 minutes after CPB
measure: Postoperative mean arterial pressure
timeFrame: Every 12 hours post-surgery for 72 hours
measure: Postoperative heart rate
timeFrame: Every 12 hours post-surgery for 72 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Minpu Li, Master
role: STUDY_CHAIR
References: