Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery

NCT ID: NCT05205720

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-11-12

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 The intravenous analgesia pump shall be withdrawn after 72 hours of use.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

Conditions

Pain, Postoperative; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NB group

Celiac 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.

Group Type: EXPERIMENTAL

Celiac plexus block

Intervention Type: 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

Intervention Type: DRUG

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

GC group

The same analgesic plan as the experimental group, except that CPB is not performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Celiac plexus block

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.

Intervention Type: PROCEDURE

Ropivacaine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minpu Li, Master

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

Li M, Fang L, Xing T, Wang C, Chen S, Yu S, Zhu J. A single-blind randomized controlled trial of celiac plexus block for analgesia after whipple surgery. BMC Anesthesiol. 2025 Apr 22;25(1):193. doi: 10.1186/s12871-025-03045-7.

Reference Type: DERIVED

PMID: 40263988 (View on PubMed)

Other Identifiers

2021-0594

Identifier Type: -

Identifier Source: org_study_id