Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06129032
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference between total opioid consumption in 24 hours', 'timeFrame': 'postoperative 24 hours', 'description': 'The study will involve monitoring the intake of opioids at specific time intervals (2nd, 4th, 6th, 12th, and 24th hours), calculating the cumulative opioid consumption until the 24th hour'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '26996986', 'type': 'BACKGROUND', 'citation': 'Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.'}, {'pmid': '26225500', 'type': 'BACKGROUND', 'citation': 'Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.', 'detailedDescription': 'This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 to 50\n* American Society of Anesthesiologists (ASA) II classification,\n* full-term and singleton pregnancies planned to undergo cesarean section\n* using Pfannenstiel incision\n* spinal anaesthesia\n\nExclusion Criteria:\n\n* whom neuraxial anaesthesia is contraindicated,\n* those who are allergic to drugs to be used in the study,\n* who refused to participate in the study,\n* those with BMI\\>35 kg/m2,\n* ASA score ≥3 or higher,\n* diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain,\n* individuals who have received opioids during the surgical procedure for intraoperative pain,\n* patients who have undergone abdominal surgery,\n* patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure,\n* those with excessive bleeding during the operation,\n* who have uterine atony,\n* those who have a drain placed in the area to be infiltrated,\n* those who cannot understand the Visual Analog Scale (VAS),\n* who have a history of drug addiction and psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT06129032', 'briefTitle': 'Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Comparing Quadratus Lumborum Type 1 Block to The Combination Of Intraperitoneal Instillation Of Local Anesthetics And Wound Infiltration For Postoperative Pain After Cesarean Delivery: A Prospective Double-Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Wound infiltration + Intraperitoneal local anaesthetic instillation', 'description': 'the surgeon will be given a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia. A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours.', 'interventionNames': ['Procedure: Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group QUADRATUS LUMBORUM BLOCK', 'description': 'In the QLB group, quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours.', 'interventionNames': ['Procedure: Group QUADRATUS LUMBORUM BLOCK (QLB)']}], 'interventions': [{'name': 'Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation', 'type': 'PROCEDURE', 'description': 'a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia.\n\nA total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision', 'armGroupLabels': ['Group Wound infiltration + Intraperitoneal local anaesthetic instillation']}, {'name': 'Group QUADRATUS LUMBORUM BLOCK (QLB)', 'type': 'PROCEDURE', 'description': 'quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance', 'armGroupLabels': ['Group QUADRATUS LUMBORUM BLOCK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayşenur Dostbil', 'role': 'CONTACT'}], 'facility': 'Atatürk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Ayşenur Dostbil', 'role': 'CONTACT', 'email': 'adostbil@hotmail.com', 'phone': '+905333677796'}, {'name': 'Ayşenur Dostbil', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ayşenur Dostbil', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Aysenur Dostbil', 'investigatorAffiliation': 'Ataturk University'}}}}