Levobupivacaine and Postoperative Pain Relief

Study Overview
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Brief Summary
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The study analysed direct levobupivacaine instillation in surgical wound and its effectiveness in postoperative pain control. Half participants received 0,5 % levobupivacaine and the other half received 0,9% saline solution

Detailed Description
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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.

Official Title
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Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial

Conditions
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Postoperative Pain, Inguinal Hernia Unilateral

Intervention / Treatment
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* Drug: Instillation of levobupivacaine in surgical wound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levobupivacaine group<br>Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure | Drug: Instillation of levobupivacaine in surgical wound<br>* 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.<br>* Other names: Acetaminophen, Ibuprofen;|
| Placebo Comparator: Control Group<br>Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure | Drug: Instillation of levobupivacaine in surgical wound<br>* 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.<br>* Other names: Acetaminophen, Ibuprofen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessment | 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 | Min 30 if no changes Hour 6 | 
| Analgesic efficacy of nonopioid analgesic mixture | 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 | as needed in 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of breakthrough pain | 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 | as needed in 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, hernia, children, levobupivacaine, instillation