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Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery

Phase 4
Completed
Conditions
Pain, Postoperative
Nerve Block
Interventions
Procedure: Celiac plexus block
Registration Number
NCT05205720
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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 The intravenous analgesia pump shall be withdrawn after 72 hours of use.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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
78
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NB groupCeliac plexus blockCeliac plexus block (CPB) was added to the postoperative analgesia plan. CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.
NB groupRopivacaineCeliac plexus block (CPB) was added to the postoperative analgesia plan. CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.
Primary Outcome Measures
NameTimeMethod
Opioid consumption72 hours after surgery

Morphine equivalent

Secondary Outcome Measures
NameTimeMethod
Press of the analgesic pumpEvery 24 hours post-surgery for 72 hours

Daily frequency of pump presses

White blood cell countAt the end of surgery and 24 hours post-surgery

Laboratory tests of white blood cell count (WBC)

C-reactive proteinAt the end of surgery and 24 hours post-surgery

Laboratory tests of C-reactive protein (CRP)

Interleukin-6At the end of surgery and 24 hours post-surgery

Laboratory tests of interleukin-6 (IL-6)

Systemic vascular resistance index changes during celiac plexus blockBefore and 5、10、20 minutes after CPB

Celiac plexus block (CPB)

Time to first flatus72 hours after surgery
Erythrocyte sedimentation rateAt the end of surgery and 24 hours post-surgery

Laboratory tests of erythrocyte sedimentation rate (ESR)

Length of postoperative hospitalizationAfter surgery to before discharge, up to 2 months
ProcalcitoninAt the end of surgery and 24 hours post-surgery

Laboratory tests of procalcitonin (PCT)

Pain scores6, 12, 24, 48, 72 hours after surgery

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

Postoperative mean arterial pressureEvery 12 hours post-surgery for 72 hours

Mean arterial pressure (MAP)

Cardiac index changes during celiac plexus blockBefore and 5、10、20 minutes after CPB

Celiac plexus block (CPB)

Postoperative heart rateEvery 12 hours post-surgery for 72 hours

Heart rate (HR)

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

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