Clinical Trials Directory

Trials / Completed

CompletedNCT06653439

Analgesic Effect of Bilateral Subcostal Quadratus Lumborum Block in Laparoscopic Colorectal Surgery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Ondokuz Mayıs University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBilateral ultrasound guided Subcostal Quadratus Lumborum BlockBilateral ultrasound-guided subcostal quadratus lumborum block (20 mL, 0.25% bupivacaine, bilaterally) will be performed. All patients will receive multimodal analgesia, including a single dose of IV tenoxicam 20 mg. Additionally, 15 mg/kg IV paracetamol (based on IBW) will be administered at skin closure and continued every 6 hours postoperatively. A standardized IV PCA protocol will be initiated using a PCA device programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum of 0.1-0.15 mg/kg (IBW). Upon arrival in the PACU, patients with a resting NRS ≥4 will receive titrated IV morphine boluses of 0.03 mg/kg (IBW; max 10 mg) every 10 minutes until pain is controlled. In the surgical ward, patients with breakthrough pain (NRS ≥4) despite PCA use will receive IV tramadol 1-1.5 mg/kg (IBW) in 50-100 mg slow doses, not exceeding 400 mg/day.All patients will receive 8 mg dexamethasone and 0.15 mg/kg ondansetron (IBW) for PONV prophylaxis.
PROCEDUREControlPatients in this group will not undergo plane blocks. IV morphine PCA multimodal analgesia will be provided: all patients will receive a single dose of IV tenoxicam 20 mg. Additionally, 15 mg/kg IV paracetamol (based on IBW) will be administered at skin closure and continued every 6 hours postoperatively. A standardized IV PCA protocol will be initiated for all patients using a PCA device, programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/kg (IBW). Upon arrival in PACU, patients with a resting NRS ≥4 will receive titrated IV morphine boluses of 0.03 mg/kg (IBW; max 10 mg) every 10 minutes until pain is controlled. In the ward, patients with breakthrough pain (NRS ≥4) despite PCA use will receive IV tramadol 1-1.5 mg/kg (IBW), administered slowly in 50-100 mg doses (max 400 mg/day). All patients will receive IV dexamethasone (8 mg) before induction and IV ondansetron (0.15 mg/kg IBW) near surgery end.
DRUGIV morphine PCAA standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/kg (IBW). No basal infusion will be used.

Timeline

Start date
2024-10-28
Primary completion
2025-04-20
Completion
2025-05-01
First posted
2024-10-22
Last updated
2025-06-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06653439. Inclusion in this directory is not an endorsement.