Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

NCT02037711 | Completed Phase 4

• 1 other identifier: SMS2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Laparoscopic; Levobupivacaine; Pediatric; Anesthesia; Instillation; surgeries

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain scoring (CHEOPS)

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

  up to six hours

Secondary Outcomes (2)

• changes in Haemodynamics including ( Heart Rate)

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

• changes in Haemodynamics including ( Non Invasive Blood Pressure)

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

Other Outcomes (1)

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

  From time of instillation of levobupivacaine till 6 hours postoperative.

Study Arms (2)

Chirocaine group (levobupivacaine )

ACTIVE COMPARATOR

Drug: Levobupivacaine 0.5%

Control group

SHAM COMPARATOR

Drug: Normal saline

Interventions

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.

Chirocaine group (levobupivacaine )

Normal saline DRUG

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

Control group

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Saad El Basha, M.D.

  Cairo University

  STUDY CHAIR

• Maha Gmail, M.D.

  Cairo University

  STUDY DIRECTOR

• Sherif M Soaida, M.D.

  Cairo University

  STUDY DIRECTOR

• hagar H Refaee

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 16, 2014
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

EG (1)