Pain, PostoperativePhase 4NCT05205720
Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
A Phase 4 study testing Celiac plexus block and Ropivacaine in people with Pain, Postoperative and Nerve Block, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Nerve Block
- What is being tested?
- Celiac plexus block and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2022to 12 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18years;
- received open Whipple surgery.
Who cannot join
- 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ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
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.
Read the 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
- Being tested
- Celiac plexus block, Ropivacaine
- Keywords
- celiac plexus block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac plexus blockProcedure or surgery
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.
RopivacaineDrug
Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.
| Study group | Role | What they receive |
|---|---|---|
| NB group | Experimental | 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. Receives: Procedure: Celiac plexus block; Drug: Ropivacaine |
| GC group | No intervention | The same analgesic plan as the experimental group, except that CPB is not performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Morphine equivalent
Measured: 72 hours after surgery
Secondary outcomes (13)
Press of the analgesic pump
Daily frequency of pump presses
Measured: Every 24 hours post-surgery for 72 hours
Time to first flatus
Measured: 72 hours after surgery
Length of postoperative hospitalization
Measured: After surgery to before discharge, up to 2 months
White blood cell count
Laboratory tests of white blood cell count (WBC)
Measured: At the end of surgery and 24 hours post-surgery
C-reactive protein
Laboratory tests of C-reactive protein (CRP)
Measured: At the end of surgery and 24 hours post-surgery
Erythrocyte sedimentation rate
Laboratory tests of erythrocyte sedimentation rate (ESR)
Measured: At the end of surgery and 24 hours post-surgery
Interleukin-6
Laboratory tests of interleukin-6 (IL-6)
Measured: At the end of surgery and 24 hours post-surgery
Procalcitonin
Laboratory tests of procalcitonin (PCT)
Measured: At the end of surgery and 24 hours post-surgery
Pain scores
VAS (0 indicates no pain and score 10 indicates the most severe pain)
Measured: 6, 12, 24, 48, 72 hours after surgery
Cardiac index changes during celiac plexus block
Celiac plexus block (CPB)
Measured: Before and 5、10、20 minutes after CPB
Systemic vascular resistance index changes during celiac plexus block
Celiac plexus block (CPB)
Measured: Before and 5、10、20 minutes after CPB
Postoperative mean arterial pressure
Mean arterial pressure (MAP)
Measured: Every 12 hours post-surgery for 72 hours
Postoperative heart rate
Heart rate (HR)
Measured: Every 12 hours post-surgery for 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start9 Mar 2022
- Primary completion12 Nov 2023
- Study completion12 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minpu Li, Master, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205720
- Sponsor's protocol ID
- 2021-0594
- Status last verified
- Feb 2024
- First submitted
- 29 Dec 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers whose proposed use of the data has been approved.
Publications
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.
PubMed 40263988
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
- ClinicalTrials.gov ID
- NCT05205720
- Acronym / sponsor ID
- 2021-0594
- Conditions
- Pain, Postoperative, Nerve Block
- Keywords
- celiac plexus block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB group | Experimental | Procedure: Celiac plexus block, Drug: RopivacaineCeliac 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. |
| GC group | No intervention | –The same analgesic plan as the experimental group, except that CPB is not performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18years;
- received open Whipple surgery.
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celiac plexus blockThe 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. | Procedure or surgery | NB group |
| RopivacaineMixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions. | Drug | NB group |
Primary outcome
Opioid consumption
Time frame: 72 hours after surgery
Morphine equivalent
13 secondary outcomes
Press of the analgesic pump
Time frame: Every 24 hours post-surgery for 72 hours
Time to first flatus
Time frame: 72 hours after surgery
Length of postoperative hospitalization
Time frame: After surgery to before discharge, up to 2 months
White blood cell count
Time frame: At the end of surgery and 24 hours post-surgery
C-reactive protein
Time frame: At the end of surgery and 24 hours post-surgery
Erythrocyte sedimentation rate
Time frame: At the end of surgery and 24 hours post-surgery
Interleukin-6
Time frame: At the end of surgery and 24 hours post-surgery
Procalcitonin
Time frame: At the end of surgery and 24 hours post-surgery
Pain scores
Time frame: 6, 12, 24, 48, 72 hours after surgery
Cardiac index changes during celiac plexus block
Time frame: Before and 5、10、20 minutes after CPB
Systemic vascular resistance index changes during celiac plexus block
Time frame: Before and 5、10、20 minutes after CPB
Postoperative mean arterial pressure
Time frame: Every 12 hours post-surgery for 72 hours
Postoperative heart rate
Time frame: Every 12 hours post-surgery for 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 40263988Li 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.
- Individual participant dataSharing planned: Yes. Researchers whose proposed use of the data has been approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minpu Li, Master study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celiac plexus block and Ropivacaine in people with Pain, Postoperative and Nerve Block, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.