Scalp Block Decreases Pain and Side Effects

NCT04133467 | Completed

• 1 other identifier: 2024
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniosynostoses; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• resumption of oral nutrition

  first postoperative day

Study Arms (2)

Group SB

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).

Other: scalp block

Group ST

intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg

Interventions

scalp block OTHER

intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)

Also known as: intravenous pharmacological approach

Group SB

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

patients with aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis

You may qualify if:

• patients undergoing cranioplasty for the correction of craniosynostosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Rossano Festa

Roma, 00168, Italy

Location

Related Publications (9)

• 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: 27977460 BACKGROUND

• 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: 22928738 BACKGROUND

• 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: 11070434 BACKGROUND

• 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: 21375097 BACKGROUND

• 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: 23477962 BACKGROUND

• 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: 8942596 BACKGROUND

• 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: 25016510 BACKGROUND

• 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: 24049457 BACKGROUND

• 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.

  PMID: 32418049 DERIVED

MeSH Terms

Conditions

Craniosynostoses; Pain, Postoperative

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rossano festa, MD

  Fondazione Universitaria Policlinico Gemelli IRCCS roma Italia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: January 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)