Levobupivacaine and Postoperative Pain Relief

Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Inguinal Hernia Unilateral

Treatments: Drug: Instillation of levobupivacaine in surgical wound

Study type: Interventional

Funder types: Other

Identifiers

NCT04869046

4042/2

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Levobupivacaine group

Experimental group

Description:

Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure

Treatment:

Drug: Instillation of levobupivacaine in surgical wound

Control Group

Placebo Comparator group

Description:

Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure

Treatment:

Drug: Instillation of levobupivacaine in surgical wound