Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Pain Clinical Trial

Official title:

Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037711
• Other study ID #: SMS2013
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2013
• Last updated: August 3, 2016
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Cairo university.
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening)		From time of instillation of levobupivacaine till 6 hours postoperative.	Yes
Primary	Postoperative Pain scoring (CHEOPS)	pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.	up to six hours	No
Secondary	changes in Haemodynamics including ( Heart Rate)	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	No
Secondary	changes in Haemodynamics including ( Non Invasive Blood Pressure)	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	No