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OpenTrials
Completed

NCT Number: NCT02037711

Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.

The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.

-But these methods are not widely used in pediatrics upon our knowledge

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing laparoscopic surgeries
  • Pediatric weighing 4 kg or more
  • Patients with free medical history

Exclusion criteria

  • Parents refusal
  • Known allergy to levobupivacaine
  • Acute preoperative pain other than biliary colic
  • chronic pain treatment or antiepileptic therapy
  • Severe hepatic or renal impairment
  • Cognitive impairment or communication problems.

Treatment and study plan

Levobupivacaine 0.5%

Drug

Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg.

normal saline

Drug

Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain

Primary outcomes

  1. Postoperative Pain scoring (CHEOPS)

    Time frame: up to six hours

    pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.

Secondary outcomes

  1. changes in Haemodynamics including ( Heart Rate)

    Time frame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6

    Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)

  2. changes in Haemodynamics including ( Non Invasive Blood Pressure)

    Time frame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6

    Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)

Other outcomes

  1. Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening)

    Time frame: From time of instillation of levobupivacaine till 6 hours postoperative.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2014
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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