Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic

June 28, 2013 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Comparison of Peripheral Nerve Blocks to Local Anesthetic

After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most children will still require additional pain medications after surgery. The purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A study investigator who is not involved in the immediate care of the patient will use a computer generated randomized table as to whether a child undergoing laparoscopic appendectomy will receive local anesthetic infiltration to the laparoscopic port placement sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia. The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the minimum amount of local anesthetic needed for a successful block. This will be the dose for each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port sites by surgeons will also be limited to a total of 14 ml. If a subject does not have adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05 mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per surgeon preference. A blinded observer will observe the subject for pain in the PACU using a validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain medications will be noted by an observer in the PACU and followed for the first 24 hours postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral nerve blocks versus local anesthetic infiltration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's hospital of Chicago

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All children scheduled for laparoscopic appendectomy between the ages of 6 and 18
  • Written informed consent from parent of guardian

Exclusion Criteria:

  • Sensitivities to local anesthetics
  • Significant renal, liver, or cardiac disease
  • Appendectomy requiring an open procedure

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peripheral Nerve Block
bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject
Drug: Bupivacaine
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.
Drug: Bupivacaine
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
Experimental: local anesthetic infiltration
local anesthetic infiltration will be administered after induction of general anesthesia
Drug: Bupivacaine
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.
Drug: Bupivacaine
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Laparoscopic appendectomy infiltration that reduces postoperative pain
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMH IRB 2008-13399

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