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NCT Number: NCT03480607

Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair

To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.

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Key information

Conditions

Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University Childeren Hospital

Al Mansurah, DK, 050, Egypt

About this study

Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.

Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American society of anesthesiologist (ASA) physical status I or II

Exclusion criteria

  • known allergy to any of drugs used
  • coagulopathy
  • any wound or infection related to puncture site
  • major illness
  • failure to gain consent of parents.

Treatment and study plan

dexmedetomidine group

Drug

0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine

Dexamethasone group

Drug

0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Primary outcomes

  1. Postoperative FLACC scale

    Time frame: for 24 hours after surgery

    FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,

  2. Postoperative sedation score

    Time frame: for 4 hours after surgery

    The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2,

Secondary outcomes

  1. Heart rate

    Time frame: For 4 hours after induction

    (beat/min)

  2. Systolic blood pressure

    Time frame: For 4 hours after induction

    (mmHg)

  3. Postoperative nausea

    Time frame: for 24 hours after surgery

    As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks.

  4. Haematoma formation after surgery

    Time frame: for 24 hours after surgery

    That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation

  5. Postoperative vomiting

    Time frame: for 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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