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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662401
Enrollment
66
Registered
2012-08-10
Start date
2008-05-31
Completion date
Unknown
Last updated
2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

children, laparoscopic appendectomy, iliohypogastric nerve block, rectus sheath nerve block, ilioinguinal nerve block

Brief summary

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.

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.

Interventions

DRUGBupivacaine

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.

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Laparoscopic appendectomy infiltration that reduces postoperative painParticipants will be followed for the duration of anesthesia and after surgery, an average of 48 hoursCompare 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026