Levobupivacaine and Postoperative Pain Relief

Phase 4

Completed

• Conditions: Inguinal Hernia Unilateral; Postoperative Pain
• Interventions: Drug: Instillation of levobupivacaine in surgical wound

• Registration Number: NCT04869046
• Lead Sponsor: Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

Brief 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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-12
• Study Completion: 2013-12-01
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-01
• Study First Posted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine group	Instillation of levobupivacaine in surgical wound	Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure
Control Group	Instillation of levobupivacaine in surgical wound	Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessment	"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
Analgesic efficacy of nonopioid analgesic mixture	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 Outcome Measures

Name	Time	Method
Control of breakthrough pain	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

Trial Locations

Locations (2)

Institute for Mother and Child Health Care Dr Vukan Cupic; 🇷🇸 Belgrade, Serbia

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