- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869046
Levobupivacaine and Postoperative Pain Relief
Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inguinal hernia is one of the most common conditions that requires elective surgical repair in children. The issue of post-operative pain in children is important, particularly because the surgical intervention per se is a stressful experience, after which the level of stressors in the recovery period should be minimized. Stress, including the pain in the postoperative period, could contribute to a delayed postoperative wound healing and recovery. Also, untreated acute pain could interfere with cognitive function, immune response as well as lead to the development of chronic postsurgical pain. For this reason, it is vital to reduce the painful sensations over the postoperative period as much as possible.
Levobupivacaine is a long-acting local anesthetic. Evidence from animal models and human volunteer participants showed that levobupivacaine has favourable effects on cardiovascular and central nervous systems. Clinical studies have also showed that levobupivacaine has a very low risk of systemic toxicity. A combination of levobupivacaine with non-opioid analgesics could have a beneficial role in the postoperative recovery from inguinal hernia surgery in terms of pain relief. The purpose of this study was to examine the effectiveness of levobupivacaine instillation combined with the routine postoperative non-opioid analgesia in children who underwent inguinal hernia repair.
It is very important for children to leave the hospital without additional support. Instilled levobupivacaine applied directly to the wound, currently interrupting transmission of the painful stimuli from the site of major trauma. The dose of applied levobupivacaine in this study is 2 times lower than that administered for caudal block and 4 times lower than the maximum dose. Analgesic effectiveness of this procedure is measured by the frequency of administration of a mixture of ibuprofen and acetaminophen over 24 hours after surgery, and duration of time between the administration of two doses.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Belgrade, Serbia, +38111
- Institut for Mother and Child HealthCare "Dr Vukan Cupic"
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Belgrade, Serbia
- Institute for Mother and Child Health Care dr Vukan Cupic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- elective surgery
- not having incarcerated hernia
- not having previous surgeries requiring general anaesthesia American Society of Anesthesia scores I and II
- not having allergy to topical anesthetics, paracetamol, ibuprofen and/or general anesthetics, opioids or muscle relaxants
Exclusion Criteria:
- worsening of health status prior to surgery
- parental withdrawal to study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Levobupivacaine group
Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure
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Once the hernia tissue had been surgically managed, the wound was sutured in layers and a solution of 0.5% levobupivacaine, 0.5 mg/kg (0.1 ml/kg), was instilled into the wound of children in the experimental group before suturing of the abdominal fascia.
That same amount of 0.9% saline was given to children in the control group.
The absorption of the solution took approximately 3 minutes, after which the wound was sutured.
After completion of wound suturing, all children received 20 mg/kg of paracetamol administered as a rectal suppository.
Other Names:
|
PLACEBO_COMPARATOR: Control Group
Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure
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Once the hernia tissue had been surgically managed, the wound was sutured in layers and a solution of 0.5% levobupivacaine, 0.5 mg/kg (0.1 ml/kg), was instilled into the wound of children in the experimental group before suturing of the abdominal fascia.
That same amount of 0.9% saline was given to children in the control group.
The absorption of the solution took approximately 3 minutes, after which the wound was sutured.
After completion of wound suturing, all children received 20 mg/kg of paracetamol administered as a rectal suppository.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain assessment
Time Frame: "Min 30" if no changes "Hour 6"
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Assessment of pain by Face, Legs, Activity, Cry Consolability scale (nurse is observer) regularly, around the clock, first time 30 minutes after surgery, than after every 6 hours, until 24 h after surgery.
Each score higher than 3 is considered significant and and an analgesic was given
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"Min 30" if no changes "Hour 6"
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Analgesic efficacy of nonopioid analgesic mixture
Time Frame: as needed in 24 hours
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30 minutes after taking analgesic mixture, the Face, Legs, Activity, Cry Consolability pain scale assessment was performed.
Each score higher than 3 is considered significant and planed nonopioid analgesic was given.
Frequency of nonsteroidal anti-inflammatory drug administration needed in 24 hour timeframe and time interval between doses were used as a measure of the analgesic effectiveness
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as needed in 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Control of breakthrough pain
Time Frame: as needed in 24 hours
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Breakthrough pain was treated with the same analgesic, in the same dose.
The total allowed daily dose is taken into account.
If it is exceeded, a dose of planned opioid analgesic is administered
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as needed in 24 hours
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Collaborators and Investigators
Investigators
- Study Director: Sonja Vuckovic, MD, PhD, University of Belgrade Faculty of Medicine
Publications and helpful links
General Publications
- Williams G, Howard RF, Liossi C. Persistent postsurgical pain in children and young people: prediction, prevention, and management. Pain Rep. 2017 Aug 21;2(5):e616. doi: 10.1097/PR9.0000000000000616. eCollection 2017 Sep.
- Matsota P, Papageorgiou-Brousta M, Kostopanagiotou G. Wound infiltration with levobupivacaine: an alternative method of postoperative pain relief after inguinal hernia repair in children. Eur J Pediatr Surg. 2007 Aug;17(4):270-4. doi: 10.1055/s-2007-965473.
- Dogra N, Dadheech R, Dhaka M, Gupta A. A study to compare caudal levobupivacaine, tramadol and a combination of both in paediatric inguinal hernia surgeries. Indian J Anaesth. 2018 May;62(5):359-365. doi: 10.4103/ija.IJA_747_17.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Pain, Postoperative
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Anesthetics, Local
- Acetaminophen
- Ibuprofen
- Levobupivacaine
- Analgesics
Other Study ID Numbers
- 4042/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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