Levobupivacaine and Postoperative Pain Relief

NCT ID: NCT04869046

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-01

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.

Conditions

Postoperative Pain; Inguinal Hernia Unilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levobupivacaine group

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

Group Type: EXPERIMENTAL

Instillation of levobupivacaine in surgical wound

Intervention Type: 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.

Control Group

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

Group Type: PLACEBO_COMPARATOR

Instillation of levobupivacaine in surgical wound

Intervention Type: 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.

Interventions

Instillation of levobupivacaine in surgical wound

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.

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mother and Child Health Institute of Serbia Dr Vukan Cupic

OTHER

Sponsor Role: lead

Responsible Party

Maja Sujica MD MS

Maja Sujica, Head of Department of Anesthesiology and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonja Vuckovic, MD, PhD

Role: STUDY_DIRECTOR

University of Belgrade Faculty of Medicine

Locations

Institut for Mother and Child HealthCare "Dr Vukan Cupic"

Belgrade, , Serbia

Institute for Mother and Child Health Care Dr Vukan Cupic

Belgrade, , Serbia

Countries

Serbia

References

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.

Reference Type: BACKGROUND

PMID: 29392231 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17806025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29910493 (View on PubMed)

Other Identifiers

4042/2

Identifier Type: -

Identifier Source: org_study_id