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Clinical Trials/NCT06653439
NCT06653439
Completed
Not Applicable

Analgesic Effect of Ultrasound-Guided Bilateral Subcostal Anterior Quadratus Lumborum Block in Laparoscopic Colorectal Surgery: A Randomized Controlled Trial

Ondokuz Mayıs University1 site in 1 country60 target enrollmentOctober 28, 2024

Overview

Phase
Not Applicable
Intervention
Bilateral ultrasound guided Subcostal Quadratus Lumborum Block
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
60
Locations
1
Primary Endpoint
Cumulative opioid consumption in the first 24 hours after surgery
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

Effective postoperative pain management is crucial for promoting early recovery and ambulation following laparoscopic colorectal surgery. Regional anesthesia techniques, like interfascial plane blocks, are increasingly being used to achieve this. The quadratus lumborum block (QLB) is a relatively new approach in abdominal surgeries, providing significant pain relief by blocking both somatic and sympathetic nerves. In particular, the anterior QLB technique allows local anesthetic to spread to the thoracic paravertebral space, making it potentially more effective for postoperative analgesia. The hypothesis of this study is that bilateral subcostal anterior QLB can reduce both postoperative pain and opioid consumption in laparoscopic colorectal surgery.

Detailed Description

Postoperative pain management is a critical factor in enhancing recovery and ambulation following laparoscopic colorectal surgery. Effective analgesia is necessary to reduce complications, improve patient comfort, and shorten hospital stays. In this context, multimodal analgesia is a commonly used strategy that combines various analgesic drugs, such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids, to manage pain more effectively by targeting different pathways. Although opioids are considered the gold standard for postoperative pain control, their use is associated with several undesirable side effects, including nausea, vomiting, dizziness, constipation, and respiratory depression. These opioid-related complications can delay recovery, increase patient discomfort, and extend hospital stays. Therefore, minimizing opioid consumption while still providing effective pain relief is a primary goal in postoperative pain management, particularly for surgeries such as laparoscopic colorectal procedures. To achieve this goal, regional anesthesia techniques have gained increasing popularity. These techniques, such as interfascial plane blocks, have the potential to reduce opioid use and improve pain control by targeting specific nerve pathways. One of the more recent approaches is the quadratus lumborum block (QLB), which involves the injection of local anesthetics near the quadratus lumborum muscle. This block is particularly useful in abdominal surgeries because it can provide pain relief by affecting both somatic and sympathetic nerves, leading to broader and more effective pain coverage. The QLB has four different approaches: anterior, lateral, posterior, and intramuscular. The anterior QLB is of particular interest in this setting because it involves the injection of local anesthetic between the quadratus lumborum and psoas muscles, potentially allowing the anesthetic to spread into the thoracic paravertebral space. This spread could result in the blockade of both the somatic nerves and the thoracic sympathetic chain, offering more comprehensive pain relief that is beneficial for abdominal surgeries like colorectal procedures. The potential advantages of the anterior QLB in laparoscopic colorectal surgery include reduced postoperative pain, decreased opioid consumption, and fewer opioid-related side effects. Additionally, regional anesthesia techniques like QLB may reduce postoperative complications, including respiratory issues, which are particularly important in abdominal surgeries that involve the diaphragm and lower thoracic nerves. In this study, the hypothesis is that bilateral subcostal anterior QLB, administered during laparoscopic colorectal surgery, will significantly reduce both postoperative pain and the need for opioids. The aim of this study is to investigate the effects of Bilateral subcostal anterior QLB on postoperative acute pain scores (0-24 hours) and 24- hour opioid consumption in patients who underwent laparoscopic colorectal surgery. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, parallel-group study. Patients will be divided into two groups: Group S-QLB: A bilateral S-QLB (20 ml 0.25% bupivacaine + 1:400.000 adrenaline, bilaterally) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours. Group Control : IV morphine-PCA will be applied postoperatively for 24 hours.

Registry
clinicaltrials.gov
Start Date
October 28, 2024
End Date
May 1, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Esra Turunc

Assistant professor

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Group S-QLB

A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

Intervention: Bilateral ultrasound guided Subcostal Quadratus Lumborum Block

Group S-QLB

A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

Intervention: IV morphine PCA

Group Control

IV morphine PCA

Intervention: Control

Group Control

IV morphine PCA

Intervention: IV morphine PCA

Outcomes

Primary Outcomes

Cumulative opioid consumption in the first 24 hours after surgery

Time Frame: Postoperative day 1

The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA-administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.

Secondary Outcomes

  • Heart Rate(Postoperative day 1)
  • Cumulative opioid consumption in the first 12 hours after surgery(Postoperative 12 hours.)
  • Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.)
  • Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
  • Time to First Opioid Demand via PCA(Postoperative day 1)
  • Extent of Sensory Block(From block administration to 30 minutes post-procedure.)
  • The number of patients who required rescue analgesia.(Postoperative day 1)
  • The patient number of Rescue antiemetic Requirement(Postoperative day 1)
  • The number of patients with complications(Postoperative 7 days on an average)
  • Mean Arterial Pressure(Postoperative day 1)
  • Time to First Mobilization(Postoperative day 3)
  • Time to First Flatus(Postoperative day 3)
  • Time to First Oral Intake(Postoperative day 3)
  • Length of Hospital Stay(Postoperative day 10)

Study Sites (1)

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