Levobupivacaine and Postoperative Pain Relief

Postoperative Pain Clinical Trial

Official title:

Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869046
• Other study ID #: 4042/2
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: December 1, 2013

Study information

• Verified date: May 2021
• Source: Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Unilateral
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Serbia	Institut for Mother and Child HealthCare "Dr Vukan Cupic"	Belgrade
Serbia	Institute for Mother and Child Health Care Dr Vukan Cupic	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"
Primary	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	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	as needed in 24 hours