Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

August 3, 2016 updated by: Sherif Mohamed Abd el moneim Soaida, MD, Cairo University

Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Faculty of Medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient undergoing laparoscopic surgeries
  2. Pediatric weighing 4 kg or more
  3. Patients with free medical history

Exclusion Criteria:

  1. Parents refusal
  2. Known allergy to levobupivacaine
  3. Acute preoperative pain other than biliary colic
  4. chronic pain treatment or antiepileptic therapy
  5. Severe hepatic or renal impairment
  6. Cognitive impairment or communication problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Drug: Normal saline
Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain
Active Comparator: Chirocaine group (levobupivacaine )
Drug: Levobupivacaine 0.5%
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure
Time Frame
Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening)
Time Frame: From time of instillation of levobupivacaine till 6 hours postoperative.
From time of instillation of levobupivacaine till 6 hours postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Saad El Basha, M.D., Cairo University
  • Study Director: Maha Gmail, M.D., Cairo University
  • Study Director: Sherif M Soaida, M.D., Cairo University
  • Principal Investigator: hagar H Refaee, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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