Levobupivacaine and Postoperative Pain Relief
Primary Purpose
Postoperative Pain, Inguinal Hernia Unilateral
Status
Completed
Phase
Phase 4
Locations
Serbia
Study Type
Interventional
Intervention
Instillation of levobupivacaine in surgical wound
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, hernia, children, levobupivacaine, instillation
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
Sites / Locations
- Institut for Mother and Child HealthCare "Dr Vukan Cupic"
- Institute for Mother and Child Health Care Dr Vukan Cupic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Levobupivacaine group
Control Group
Arm Description
Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure
Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Control of breakthrough pain
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
Full Information
NCT ID
NCT04869046
First Posted
February 3, 2020
Last Updated
May 1, 2021
Sponsor
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
1. Study Identification
Unique Protocol Identification Number
NCT04869046
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia Unilateral
Keywords
postoperative pain, hernia, children, levobupivacaine, instillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levobupivacaine group
Arm Type
Experimental
Arm Description
Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure
Intervention Type
Drug
Intervention Name(s)
Instillation of levobupivacaine in surgical wound
Other Intervention Name(s)
Enteral analgesic mixture acetaminophen 10 mg/kg and ibuprofen 5mg/kg if needed, Acetaminophen, Ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain assessment
Description
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
Time Frame
"Min 30" if no changes "Hour 6"
Title
Analgesic efficacy of nonopioid analgesic mixture
Description
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
Time Frame
as needed in 24 hours
Secondary Outcome Measure Information:
Title
Control of breakthrough pain
Description
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
Time Frame
as needed in 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Vuckovic, MD, PhD
Organizational Affiliation
University of Belgrade Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Institut for Mother and Child HealthCare "Dr Vukan Cupic"
City
Belgrade
ZIP/Postal Code
+38111
Country
Serbia
Facility Name
Institute for Mother and Child Health Care Dr Vukan Cupic
City
Belgrade
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29392231
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.
Results Reference
background
PubMed Identifier
17806025
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.
Results Reference
background
PubMed Identifier
29910493
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.
Results Reference
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Levobupivacaine and Postoperative Pain Relief
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