Clinical trial NCT04869046: Levobupivacaine and Postoperative Pain Relief
Official title: Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Inguinal Hernia Unilateral
Keywords: postoperative pain
hernia
children
levobupivacaine
instillation
Lead sponsor: Mother and Child Health Institute of Serbia Dr Vukan Cupic
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain assessment
timeFrame: "Min 30" if no changes "Hour 6"
measure: Analgesic efficacy of nonopioid analgesic mixture
timeFrame: as needed in 24 hours
Secondary outcomes:
measure: Control of breakthrough pain
timeFrame: as needed in 24 hours
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institut for Mother and Child HealthCare "Dr Vukan Cupic"
city: Belgrade
country: Serbia
facility: Institute for Mother and Child Health Care Dr Vukan Cupic
Study officials:
affiliation: University of Belgrade Faculty of Medicine
name: Sonja Vuckovic, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Williams G, Howard RF, Liossi C. Persistent postsurgical pain in children and young people: prediction, prevention, and management. Pain Rep. 2017 Aug 21;2(5):e616. doi: 10.1097/PR9.0000000000000616. eCollection 2017 Sep.
citation: Matsota P, Papageorgiou-Brousta M, Kostopanagiotou G. Wound infiltration with levobupivacaine: an alternative method of postoperative pain relief after inguinal hernia repair in children. Eur J Pediatr Surg. 2007 Aug;17(4):270-4. doi: 10.1055/s-2007-965473.
citation: Dogra N, Dadheech R, Dhaka M, Gupta A. A study to compare caudal levobupivacaine, tramadol and a combination of both in paediatric inguinal hernia surgeries. Indian J Anaesth. 2018 May;62(5):359-365. doi: 10.4103/ija.IJA_747_17.