Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04467463
Other study ID # N-98-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date December 2020

Study information

Verified date June 2020
Source Cairo University
Contact Sherif Abdullah Mohamed, M.D.
Phone +201002013497
Email dr.sherif213@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria: - ASA I-III scheduled to undergo palatoplasty Exclusion Criteria: - bleeding disorders, - skin lesions or wounds at site of proposed needle insertion, - congenital heart disease, - respiratory or - cardiovascular disorders, - children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting, - known hypersensitivity to local anesthetics or opioids and - lack of parental consent.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
peripheral nerve block by 0.25% levobupivacaine
SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.

Locations

Country Name City State
Egypt anesthesia department at Cairo University Cairo
Egypt Cairo University hospitals Cairo Manial

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.

Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. — View Citation

Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. Review. — View Citation

Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain score Pain assessment was done immediately postoperative using Objective behavioral pain score the first 12 postoperative hours
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A