Levobupivacaine and Postoperative Pain Relief

NCT04869046 | Completed Phase 4 DMC

• 1 other identifier: 4042/2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Postoperative Pain; Inguinal Hernia Unilateral

Keywords

postoperative pain; hernia; children; levobupivacaine; instillation

Outcome Measures

Primary Outcomes (2)

• Postoperative pain assessment

  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

  "Min 30" if no changes "Hour 6"

• Analgesic efficacy of nonopioid analgesic mixture

  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

  as needed in 24 hours

Secondary Outcomes (1)

• Control of breakthrough pain

  as needed in 24 hours

Study Arms (2)

Levobupivacaine group

EXPERIMENTAL

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

Drug: Instillation of levobupivacaine in surgical wound

Control Group

PLACEBO COMPARATOR

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

Drug: Instillation of levobupivacaine in surgical wound

Interventions

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.

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

Control Group; Levobupivacaine group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• worsening of health status prior to surgery
• parental withdrawal to study

Sponsors & Collaborators

• Mother and Child Health Institute of Serbia Dr Vukan Cupic: lead

Study Sites (2)

Institut for Mother and Child HealthCare "Dr Vukan Cupic"

Belgrade, +38111, Serbia

Location

Institute for Mother and Child Health Care Dr Vukan Cupic

Belgrade, Serbia

Location

Related Publications (3)

• 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.

  PMID: 29392231 BACKGROUND

• 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.

  PMID: 17806025 BACKGROUND

• 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.

  PMID: 29910493 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hernia

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Sonja Vuckovic, MD, PhD

  University of Belgrade Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maja Sujica, Head of Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: May 3, 2021
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)