Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT04965194
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2021-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2021-07-03', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total analgesic consumption', 'timeFrame': '24 hours', 'description': 'total fentanyl consumption as rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'Time of first analgesic request.', 'timeFrame': '24 hours', 'description': 'first dose of rescue analgesia'}, {'measure': 'dynamic Visual analogue pain score', 'timeFrame': '24 hours', 'description': 'degree of pain description on movement from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain'}, {'measure': 'resting Visual analogue pain score', 'timeFrame': '24 hours', 'description': 'degree of pain description on rest from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESPB', 'QLPB', 'analgesia', 'postoperative pain'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': "The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.\n\nThis prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study.\n\nAccording to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one).\n\nGroup I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.", 'detailedDescription': 'Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.\n\nPrimary outcome:\n\nTotal analgesic consumption in the first 24hrs postoperative.\n\nSecondary outcomes:\n\n1. Time of first analgesic request.\n2. Visual analogue pain score in the first 24hrs postoperative\n3. Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery.\n\nIn ES group: superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T7. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.\n\nIn QL group: A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient\'s flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.\n\nBefore the end of the surgery all patients will receive 1g of paracetamol IV, at the end of the surgery reversal of neuromuscular blockade will be done by neostigmine and atropine and then the patients will be transferred to recovery room. 30 mg of ketorolac will be given to all patients every 8 hrs.\n\nParameters will be assessed:\n\nIntraoperative:\n\nHemodynamics after induction of anesthesia, after block and then every 15min till the end of surgery.\n\nPostoperative:\n\n1. Hemodynamics immediately after recovery and then 1, 2, 4, 8, 12, 16, 20and 24 hrs postoperative.\n2. VAS in the same previous intervals.\n3. Time of first analgesic request.\n4. Total analgesic requirement in the first 24 hrs. postoperative.\n5. Incidence of side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-60 years.\n* ASA I-II.\n* Both sexes.\n* Open laparotomies.\n\nExclusion Criteria:\n\n1. Patient refusal\n2. Allergy to local anesthetics\n3. BMI \\>40 kg/m2\n4. Bleeding diathesis or history of anticoagulant use.\n5. Psychiatric diseases.\n6. Infection of the skin at the site of needle punctures area.'}, 'identificationModule': {'nctId': 'NCT04965194', 'briefTitle': 'Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparotomies: Randomized Controlled Study', 'orgStudyIdInfo': {'id': '50:6/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block (ESPB)', 'description': '20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side', 'interventionNames': ['Procedure: erector spinae plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Quadratus lumborum plane block (QLPB)', 'description': 'The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.', 'interventionNames': ['Procedure: Quadratus lumborum plane block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'patients received no regional block', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.', 'armGroupLabels': ['Erector spinae plane block (ESPB)']}, {'name': 'Quadratus lumborum plane block', 'type': 'PROCEDURE', 'description': 'A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient\'s flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.', 'armGroupLabels': ['Quadratus lumborum plane block (QLPB)']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'patients received no regional block', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Minia University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Shadwa R Mohamed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mina university hospital'}, {'name': 'Ahmed H Mohamed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minia Universiry hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Shadwa Rabea Mohamed', 'investigatorAffiliation': 'Minia University'}}}}