Levobupivacaine and Postoperative Pain Relief
Condition: Postoperative Pain; Inguinal Hernia Unilateral
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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.
    

Intervention name(s): Instillation of levobupivacaine in surgical wound
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Enteral analgesic mixture acetaminophen 10 mg/kg and ibuprofen 5mg/kg if needed; Acetaminophen, Ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Analgesics; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; hernia; children; levobupivacaine; instillation