Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05205720
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-23', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': '72 hours after surgery', 'description': 'Morphine equivalent'}], 'secondaryOutcomes': [{'measure': 'Press of the analgesic pump', 'timeFrame': 'Every 24 hours post-surgery for 72 hours', 'description': 'Daily frequency of pump presses'}, {'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', 'description': 'Laboratory tests of white blood cell count (WBC)'}, {'measure': 'C-reactive protein', 'timeFrame': 'At the end of surgery and 24 hours post-surgery', 'description': 'Laboratory tests of C-reactive protein (CRP)'}, {'measure': 'Erythrocyte sedimentation rate', 'timeFrame': 'At the end of surgery and 24 hours post-surgery', 'description': 'Laboratory tests of erythrocyte sedimentation rate (ESR)'}, {'measure': 'Interleukin-6', 'timeFrame': 'At the end of surgery and 24 hours post-surgery', 'description': 'Laboratory tests of interleukin-6 (IL-6)'}, {'measure': 'Procalcitonin', 'timeFrame': 'At the end of surgery and 24 hours post-surgery', 'description': 'Laboratory tests of procalcitonin (PCT)'}, {'measure': 'Pain scores', 'timeFrame': '6, 12, 24, 48, 72 hours after surgery', 'description': 'VAS (0 indicates no pain and score 10 indicates the most severe pain)'}, {'measure': 'Cardiac index changes during celiac plexus block', 'timeFrame': 'Before and 5、10、20 minutes after CPB', 'description': 'Celiac plexus block (CPB)'}, {'measure': 'Systemic vascular resistance index changes during celiac plexus block', 'timeFrame': 'Before and 5、10、20 minutes after CPB', 'description': 'Celiac plexus block (CPB)'}, {'measure': 'Postoperative mean arterial pressure', 'timeFrame': 'Every 12 hours post-surgery for 72 hours', 'description': 'Mean arterial pressure (MAP)'}, {'measure': 'Postoperative heart rate', 'timeFrame': 'Every 12 hours post-surgery for 72 hours', 'description': 'Heart rate (HR)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['celiac plexus block'], 'conditions': ['Pain, Postoperative', 'Nerve Block']}, 'referencesModule': {'references': [{'pmid': '40263988', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nAnesthesia protocol: the standard anesthesia protocol for open Whipple surgery in our hospital was adopted.\n\nPostoperative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18years;\n2. received open Whipple surgery.\n\nExclusion Criteria:\n\n1. patients unable to cooperate with evaluations;\n2. patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;\n3. non-standard surgical procedures, planned postoperative ICU admission;\n4. American Society of Anesthesiologists (ASA) classification of 4 or 5.\n\nWithdrawal criteria:\n\nPatients 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.'}, 'identificationModule': {'nctId': 'NCT05205720', 'briefTitle': 'Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery', 'orgStudyIdInfo': {'id': '2021-0594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NB group', 'description': 'Celiac plexus block (CPB) was added to the postoperative analgesia plan.\n\nCPB: 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.', 'interventionNames': ['Procedure: Celiac plexus block', 'Drug: Ropivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'GC group', 'description': 'The same analgesic plan as the experimental group, except that CPB is not performed.'}], 'interventions': [{'name': 'Celiac plexus block', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['NB group']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.', 'armGroupLabels': ['NB group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Minpu Li, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'With publication', 'ipdSharing': 'YES', 'description': 'Researchers whose proposed use of the data has been approved.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}