A Phase 4 interventional study of Instillation of levobupivacaine in surgical wound in Postoperative Pain and Inguinal Hernia Unilateral, sponsored by Mother and Child Health Institute of Serbia Dr Vukan Cupic. Completed at 2 sites in Serbia. Open to participants aged 6 Months to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Mother and Child Health Institute of Serbia Dr Vukan Cupic · Phase 4, Interventional, and Treatment
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
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Mother and Child Health Institute of Serbia Dr Vukan Cupic is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure
Drug: Instillation of levobupivacaine in surgical wound
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.
Also known as: Enteral analgesic mixture acetaminophen 10 mg/kg and ibuprofen 5mg/kg if needed, Acetaminophen, Ibuprofen
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
Time frame: "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
Time frame: as needed in 24 hours
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
Time frame: as needed in 24 hours
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Mother and Child Health Institute of Serbia Dr Vukan Cupic