NCT04614259

Brief Summary

Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

16 days

First QC Date

October 21, 2020

Last Update Submit

November 3, 2020

Conditions

Perioperative Complication Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    Total rescue doses of morphine

    24 huors

Study Arms (2)

intravenous analgesia

EXPERIMENTAL
Combination Product: i.v. analgesia

infraorbital nerve block

EXPERIMENTAL
Drug: Bupivacain

Interventions

BupivacainDRUG

The infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen. After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). \[104\] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis

infraorbital nerve block
i.v. analgesiaCOMBINATION_PRODUCT

Using inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular . Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes

intravenous analgesia

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • good physical condition.
  • Age 6 months to 3 years.
  • Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

You may not qualify if:

  • Children posted for combined procedures like congenital heart correction with palatoplasty .
  • Parents refusal .
  • Bleeding disorders( platelets count \< 100.000 , international ratio \>1.5).
  • Skin lesions or wounds at site of needle insertion .
  • Co-morbidities as congenital heart disease , lung pathology or central nervous system
  • Known hypersensitivity to local anesthetics or opioids .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.

    PMID: 460932BACKGROUND

  • 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. doi: 10.1001/jama.294.8.947.

    PMID: 16118385BACKGROUND

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

    BACKGROUND

  • Doyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.

    BACKGROUND

  • Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x.

    PMID: 12358652BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 3, 2020

Study Start

November 15, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Do not share