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Completed

NCT Number: NCT04869046

Levobupivacaine and Postoperative Pain Relief

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

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Key information

Conditions

Postoperative Pain Hernia Inguinal Hernia Unilateral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut for Mother and Child HealthCare "Dr Vukan Cupic", Belgrade, Serbia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instillation of levobupivacaine in surgical wound

Drug

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: Enteral analgesic mixture acetaminophen 10 mg/kg and ibuprofen 5mg/kg if needed, Acetaminophen, Ibuprofen

Primary outcomes

  1. Postoperative pain assessment

    Time frame: "Min 30" if no changes "Hour 6"

    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

  2. Analgesic efficacy of nonopioid analgesic mixture

    Time frame: as needed in 24 hours

    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

Secondary outcomes

  1. Control of breakthrough pain

    Time frame: as needed in 24 hours

    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

Sponsors and collaborators

Lead sponsor

Mother and Child Health Institute of Serbia Dr Vukan Cupic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 3, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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