Pain, Postoperative Clinical Trial
Official title:
The Scalp Block for Postoperative Pain Control in Craniosynostosis Surgery: a Case Control Study
NCT number | NCT04133467 |
Other study ID # | 2024 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | June 30, 2016 |
Verified date | October 2019 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | June 30, 2016 |
Est. primary completion date | June 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 2 Years |
Eligibility |
Inclusion Criteria: - patients undergoing cranioplasty for the correction of craniosynostosis Exclusion Criteria: - allergies to local anesthetics and/or analgesics - specific drug therapies (pain relievers, sedatives and/or epileptic) - denied consent to the study; development of postoperative intracranical bleeding and/or gastrointestinal bleeding - need of nasogastric tube - development of gastrointestinal infections. |
Country | Name | City | State |
---|---|---|---|
Italy | Rossano Festa | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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. — View Citation
Guilfoyle MR, Helmy A, Duane D, Hutchinson PJ. Regional scalp block for postcraniotomy analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 May;116(5):1093-102. doi: 10.1213/ANE.0b013e3182863c22. Epub 2013 Mar 11. Review. — View 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. — View 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. — View 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. — View 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. — View Citation
Teo JH, Palmer GM, Davidson AJ. Post-craniotomy pain in a paediatric population. Anaesth Intensive Care. 2011 Jan;39(1):89-94. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain intensity | Objective Pain Score incorporates four pain behaviors (crying, movement, agitation, and verbalization) and was evaluated at following times: 30 minutes after extubation (T0) 2 hours after extubation (T1) 4 hours after extubation (T2) 8 hours after extubation (T3) at discharge from Pediatric Intensive Care Unit (T4). at in the Neurosurgical ward OPS was assessed every eight hours, until the fifth day of hospitalization. |
OPS was assessed until the fifth day of hospitalization. | |
Secondary | resumption of oral nutrition | evaluation of post-operative feeding recovery time | first postoperative day |
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