Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement

Not Applicable

Withdrawn

• Conditions: Postoperative Pain
• Interventions: Procedure: laparoscopic guided nerve blocks; Drug: Ropivacaine

• Registration Number: NCT02945696
• Lead Sponsor: Marcus Malek

Brief Summary

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

Detailed Description

Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients 5 - 17 years old.
2. Patients undergoing laparoscopic procedures
3. Patients that weigh greater than or equal to 34 kg and less than 100 kg.

Exclusion Criteria

1. Patients who underwent open surgical procedures will be excluded from this study.
2. Patients that weigh less than 34kg.
3. Patients that weigh more than 100 kg.
4. Perforated appendicitis.
5. Bowel obstruction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic guided nerve blocks	laparoscopic guided nerve blocks	These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.
Laparoscopic guided nerve blocks	Ropivacaine	These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.

Primary Outcome Measures

Name	Time	Method
Minutes under anesthesia	2 years

Secondary Outcome Measures

Name	Time	Method
Pain scores	2 years
Narcotic usage	2 years