Clinical trial NCT02945696: Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
Official title: Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Pain
Keywords: nerve block
laparoscopy
anesthesia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Minutes under anesthesia
timeFrame: 2 years
Secondary outcomes:
measure: Pain scores
timeFrame: 2 years
measure: Narcotic usage
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: