Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04133467
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2019-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scalp Block Decreases Pain and Side Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003398', 'term': 'Craniosynostoses'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D013580', 'term': 'Synostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-19', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'OPS was assessed until the fifth day of hospitalization.', 'description': 'Objective Pain Score incorporates four pain behaviors (crying, movement, agitation, and verbalization) and was evaluated at following times:\n\n* 30 minutes after extubation (T0)\n* 2 hours after extubation (T1)\n* 4 hours after extubation (T2)\n* 8 hours after extubation (T3)\n* at discharge from Pediatric Intensive Care Unit (T4).\n* at in the Neurosurgical ward OPS was assessed every eight hours, until the fifth day of hospitalization.'}], 'secondaryOutcomes': [{'measure': 'resumption of oral nutrition', 'timeFrame': 'first postoperative day', 'description': 'evaluation of post-operative feeding recovery time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Craniosynostoses', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '27977460', 'type': 'BACKGROUND', 'citation': 'Stricker PA, Goobie SM, Cladis FP, Haberkern CM, Meier PM, Reddy SK, Nguyen TT, Cai L, Polansky M, Szmuk P, Fiadjoe J, Soneru C, Falcon R, Petersen T, Kowalczyk-Derderian C, Dalesio N, Budac S, Groenewald N, Rubens D, Thompson D, Watts R, Gentry K, Ivanova I, Hetmaniuk M, Hsieh V, Collins M, Wong K, Binstock W, Reid R, Poteet-Schwartz K, Gries H, Hall R, Koh J, Bannister C, Sung W, Jain R, Fernandez A, Tuite GF, Ruas E, Drozhinin O, Tetreault L, Muldowney B, Ricketts K, Fernandez P, Sohn L, Hajduk J, Taicher B, Burkhart J, Wright A, Kugler J, Barajas-DeLoa L, Gangadharan M, Busso V, Stallworth K, Staudt S, Labovsky KL, Glover CD, Huang H, Karlberg-Hippard H, Capehart S, Streckfus C, Nguyen KT, Manyang P, Martinez JL, Hansen JK, Levy HM, Brzenski A, Chiao F, Ingelmo P, Mujallid R, Olutoye OA, Syed T, Benzon H, Bosenberg A; Pediatric Craniofacial Collaborative Group. Perioperative Outcomes and Management in Pediatric Complex Cranial Vault Reconstruction: A Multicenter Study from the Pediatric Craniofacial Collaborative Group. Anesthesiology. 2017 Feb;126(2):276-287. doi: 10.1097/ALN.0000000000001481.'}, {'pmid': '22928738', 'type': 'BACKGROUND', 'citation': 'Thomas K, Hughes C, Johnson D, Das S. Anesthesia for surgery related to craniosynostosis: a review. Part 1. Paediatr Anaesth. 2012 Nov;22(11):1033-41. doi: 10.1111/j.1460-9592.2012.03927.x.'}, {'pmid': '11070434', 'type': 'BACKGROUND', 'citation': 'Chiaretti A, Pietrini D, Piastra M, Polidori G, Savioli A, Velardi F, Ciano F, Di Rocco C. Safety and efficacy of remifentanil in craniosynostosis repair in children less than 1 year old. Pediatr Neurosurg. 2000 Aug;33(2):83-8. doi: 10.1159/000028981.'}, {'pmid': '21375097', 'type': 'BACKGROUND', 'citation': 'Teo JH, Palmer GM, Davidson AJ. Post-craniotomy pain in a paediatric population. Anaesth Intensive Care. 2011 Jan;39(1):89-94. doi: 10.1177/0310057X1103900115.'}, {'pmid': '23477962', 'type': 'BACKGROUND', 'citation': 'Guilfoyle MR, Helmy A, Duane D, Hutchinson PJA. Regional scalp block for postcraniotomy analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 May;116(5):1093-1102. doi: 10.1213/ANE.0b013e3182863c22. Epub 2013 Mar 11.'}, {'pmid': '8942596', 'type': 'BACKGROUND', 'citation': 'Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.'}, {'pmid': '25016510', 'type': 'BACKGROUND', 'citation': 'Pardey Bracho GF, Pereira de Souza Neto E, Grousson S, Mottolese C, Dailler F. Opioid consumption after levobupivacaine scalp nerve block for craniosynostosis surgery. Acta Anaesthesiol Taiwan. 2014 Jun;52(2):64-9. doi: 10.1016/j.aat.2014.05.006. Epub 2014 Jun 21.'}, {'pmid': '24049457', 'type': 'BACKGROUND', 'citation': 'Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013 Sep 9;6:683-9. doi: 10.2147/JPR.S42262. eCollection 2013.'}, {'pmid': '32418049', 'type': 'DERIVED', 'citation': 'Festa R, Tosi F, Pusateri A, Mensi S, Garra R, Mancino A, Frassanito P, Rossi M. The scalp block for postoperative pain control in craniosynostosis surgery: a case control study. Childs Nerv Syst. 2020 Dec;36(12):3063-3070. doi: 10.1007/s00381-020-04661-z. Epub 2020 May 17.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes. The objective of this observational case- control study was to evaluate the effectiveness of an analgesic technique based on the scalp block versus traditional pharmacological approach.', 'detailedDescription': 'Several studies on craniosynostosis and the correlated risk factors have been published, the majority of them focusing on the perioperative management of blood losses and avoidance of haemorrhagic shock. Other issues related to anaesthetic management of the surgical correction of craniosynostosis are metabolic and electrolyte disturbances.\n\nEven if craniosynostosis surgery is an invasive procedure, there is a current misconception that it would be associated with minimal pain, despite the extensive exhibition of the skull and periostea dissection. The Literature about the assessment and management of postoperative pain in this particular surgical setting is scarce. Assessment of pain in infants is challenging, and often relies on clinical observation. To date, there are no evaluative and therapeutic parameters globally accredited in this category of patients. The scalp nerve block (SNB) is a regional anaesthetic technique, performed since several years in children undergoing a variety of procedures, from neurosurgery to eye-nose-throat surgery.SNB has been proposed as a complement to the routine craniosynostosis anaesthetic protocol, and should be associated to a reduced need for opioids.\n\nThirteen patients, aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis were subjected to SNB (Group SB) with Levobupivacaine 0.125% (total dose 2 mg/kg), performed before awakening, in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight \\>10Kg, 7 mg/kg if body weight \\< 10 kg). The SNB procedure was performed using the modified Pinosky technique, with levobupivacaine 0,125%(10). A targeted infiltration of 0,75-2ml of local anaesthetic (LA) solution was done at multiple sites with a 23G needle.\n\nThis Group of patients were compared with another group of 13 patients, derived from our database, and treated with the traditional pharmacological approach given intraoperatively (intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing cranioplasty for the correction of craniosynostosis\n\nExclusion Criteria:\n\n* allergies to local anesthetics and/or analgesics\n* specific drug therapies (pain relievers, sedatives and/or epileptic)\n* denied consent to the study; development of postoperative intracranical bleeding and/or gastrointestinal bleeding\n* need of nasogastric tube\n* development of gastrointestinal infections.'}, 'identificationModule': {'nctId': 'NCT04133467', 'briefTitle': 'Scalp Block Decreases Pain and Side Effects', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'The Scalp Block for Postoperative Pain Control in Craniosynostosis Surgery: a Case Control Study', 'orgStudyIdInfo': {'id': '2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group SB', 'description': 'Scalp block performed with Levobupivacaine 0.125% (total dose 2 mg/kg) in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight \\>10Kg, 7 mg/kg if body weight \\< 10 kg).', 'interventionNames': ['Other: scalp block']}, {'label': 'Group ST', 'description': 'intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg'}], 'interventions': [{'name': 'scalp block', 'type': 'OTHER', 'otherNames': ['intravenous pharmacological approach'], 'description': 'intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)', 'armGroupLabels': ['Group SB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Rossano Festa', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Rossano festa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Universitaria Policlinico Gemelli IRCCS roma Italia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}