Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair
Primary Purpose
Cleft Palate Children, Block
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
suprazygomatic maxillary nerve block
surgical site infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate Children focused on measuring bupivacaine, suprazygomatic nerve block
Eligibility Criteria
Inclusion Criteria:
- ASA grade I-III.
- Aged from1-5 years
- Undergoing cleft palate repair.
Exclusion Criteria:
- Patient's refusal.
- Allergy to local anaesthetics.
- Trigeminal neuralgia.
- Bleeding diathesis.
- Inflammation or infection over injection site.
Sites / Locations
- Assiut university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
suprazygomatic maxillary nerve block
surgical site infiltraion
Arm Description
the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg.
the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.
Outcomes
Primary Outcome Measures
Pain assessment
By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.
Cry No crying +1 Moaning,crying +2 Screaming+3
Facial expression: Smiling +1 Composed, neutral +2 Grimace +3
Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3
Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3
Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is > 4.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03799068
Brief Title
Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair
Official Title
Comparative Study of Bilateral Suprazygomatic Maxillary Nerve Block and Surgical Site Infiltration for Perioperative Analgesia in Children Undergoing Cleft Palate Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with peri-incisional infiltration with the same agent for perioperative analgesia in children undergoing cleft palate repair.
Detailed Description
Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births, Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 h following surgery.
Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs), surgical site infiltration and various nerve blocks However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia. These became established in paediatric anaesthetic practice with the accumulating evidence of advantages such as postoperative pain relief, reduced use of potent narcotics, rapid return of alertness, early feeding and moving about, and early discharge in day care surgery.
The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra- orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate.
Maxillary nerve block through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has lead to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury In adults, approach to the suprazygomatic MN block (SMB) seems to minimize the risks of the infrazygomatic route providing effective anaesthesia of the entire sensory territory of the MN and its terminal branches.
Bupivacaine, a long-acting amide local anaesthetic has been used widely in infants, particularly for infiltration of wound-edges and nerve blocking.
Pre-incisional infiltration of local anaesthetics has been used both in adults and children in a variety of surgeries with variable results. submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate Children, Block
Keywords
bupivacaine, suprazygomatic nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
suprazygomatic maxillary nerve block
Arm Type
Active Comparator
Arm Description
the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg.
Arm Title
surgical site infiltraion
Arm Type
Active Comparator
Arm Description
the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.
Intervention Type
Other
Intervention Name(s)
suprazygomatic maxillary nerve block
Intervention Description
bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side.
Intervention Type
Other
Intervention Name(s)
surgical site infiltration
Intervention Description
peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.
Primary Outcome Measure Information:
Title
Pain assessment
Description
By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.
Cry No crying +1 Moaning,crying +2 Screaming+3
Facial expression: Smiling +1 Composed, neutral +2 Grimace +3
Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3
Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3
Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is > 4.
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA grade I-III.
Aged from1-5 years
Undergoing cleft palate repair.
Exclusion Criteria:
Patient's refusal.
Allergy to local anaesthetics.
Trigeminal neuralgia.
Bleeding diathesis.
Inflammation or infection over injection site.
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair
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