Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy

NCT03581539 | Completed DMC

• 1 other identifier: 1801979369
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

All three methods of postoperative analgesia have been shown to decrease postoperative pain control in nephrectomy patients, the three methods have never been compared to each other. This study aims to compare three different pain techniques proven to be beneficial in surgical nephrectomies, including the efficacy and the side effects of each technique.

Conditions

Nephrectomy

Keywords

Laparoscopic Nephrectomy,; Simple Nephrectomy; Partial Nephrectomy; Pain,acute; Pain,postoperative

Outcome Measures

Primary Outcomes (2)

• Primary endpoint of this study will be VAS pain score at 24 hours

  The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 24 hours after surgery

• Primary endpoint of this study will be VAS pain score at 48 hours

  Pain scores will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 48 hours after surgery

Secondary Outcomes (1)

• Secondary endpoint includes total IV and PO (By Mouth) opioid consumption at 72 hours

  Opioid consumption will be measured at 1 hour post op, 24, 48, and 72 hours post op. The total amount will be recorded

Other Outcomes (4)

• Average Nausea scores over 72 hours

  Nausea scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged

• Average Sedation scores over 72 hours

  Sedation scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged

• Subjects overall satisfaction scores

  Post operatively at hour 24

Study Arms (3)

Group #1

ACTIVE COMPARATOR

Transverses Abdominis Plane (TAP) block

Procedure: Transverses Abdominis Plane (TAP) block

Group #2

ACTIVE COMPARATOR

Quadratus Lumborum (QL) block

Procedure: Quadratus Lumborum (QL) block

Group #3

ACTIVE COMPARATOR

Surgeon Infiltration using Exparel

Procedure: Surgeon Infiltration using Exparel

Interventions

Transverses Abdominis Plane (TAP) block PROCEDURE

TAP block - Participants will get an injection of bupivacaine and exparel (numbing medicine) in the four different locations of your stomach. To be more specific, the injection placed between your oblique muscles in four different locations right after you are asleep and just before the start of surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.

Group #1

Quadratus Lumborum (QL) block PROCEDURE

QL block - Participants will get an injection of bupivacaine with exparel (numbing medicine) in two locations in your lower stomach. To be more specific, an injection will take place inside your quadratus lumborum muscle which is slightly deeper than your oblique muscles right after you are asleep and right before surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.

Group #2

Surgeon Infiltration using Exparel PROCEDURE

SI group - at the end of the surgery and just prior to you waking up, the surgeon will use a needle to inject the surgical incision site with bupivacaine and exparel (numbing medicine) spreading the medicine evenly as the needle is slowly withdrawn to make sure all layers are evenly filled with the medicine that will numb the area.

Group #3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic nephrectomy including partial, simple and radical nephrectomy
• ASA class 1, 2, 3 or 4
• Age 18 or older, male or female

You may not qualify if:

• Any contraindication for TAP block, QL block or surgeon infiltration
• Donor Nephrectomy
• History of substance abuse in the past 6 months
• Patients on more than 30mg po morphine equivalents of opioids, staff anesthesiologist will confirm this portion prior to enrollment.
• Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
• Known allergy to bupivacaine or Exparel
• Patients \<40kg or \>110 kg TBW

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Kevin M Backfish-White, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: Patients randomized to four-quadrant Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block or surgeon infiltration using Exparel for postoperative analgesia after laparoscopic nephrectomy

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 10, 2018
• Study Start: May 22, 2018
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

US (1)