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Completed

NCT Number: NCT06653439

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

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.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Regional Anesthesia Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

They will be aged between 18 and 75 years. They will have an American Society of Anesthesiologists (ASA) physical status classification of I to III.

They will be able to provide written informed consent.

Exclusion criteria

They will refuse to participate. They will have a body mass index (BMI) greater than 35 kg/m². They will have contraindications to peripheral nerve blocks (e.g., coagulopathy, abnormal INR, thrombocytopenia, local or systemic infection).

They will have clinically significant cardiovascular or cerebrovascular disease.

They will have severe hepatic, renal, or respiratory dysfunction. They will have known drug allergies. They will have a history of substance abuse. They will have chronic opioid use, defined as regular use of ≥15 mg oral morphine equivalent per day for at least 30 consecutive days within the past 3 months.

They will have chronic pain syndromes (e.g., fibromyalgia, diabetic neuropathy, or chronic low back pain).

They will have neuropsychiatric disorders or cognitive impairment that precludes effective communication with the investigators.

Treatment and study plan

Bilateral ultrasound guided Subcostal Quadratus Lumborum Block

Procedure

Bilateral 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.

Other names: S-QLB group

Control

Procedure

Patients 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.

Other names: Control group

IV morphine PCA

Drug

A 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.

Other names: PCA

Primary outcomes

  1. 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

  1. Cumulative opioid consumption in the first 12 hours after surgery

    Time frame: Postoperative 12 hours.

    The secondary outcome will be defined as cumulative opioid consumption during the first 12 hours following surgery, calculated in intravenous morphine milligram equivalents (IV-MME). This will include both PCA-administered morphine and rescue intravenous tramadol, in accordance with the standardized ESAIC conversion guidelines. Patients may request opioids using a PCA device when their NRS score is ≥ 4.

  2. Intraoperative Remifentanil Consumption

    Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.

    Total intraoperative remifentanil consumption will be recorded in micrograms (µg) from the start of anesthesia induction until the end of surgery.

  3. Numerical Rating Scale Assessment of Postoperative Pain

    Time frame: Postoperative day 1

    Pain scores will be assessed using the 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 represents the worst imaginable pain. Evaluations will be performed both at rest (static) and during coughing or deep breathing (dynamic). Assessments will be conducted in the post-anesthesia care unit (PACU) after extubation and once communication is established, and subsequently at 3, 6, 12, 18, and 24 hours postoperatively.

  4. Time to First Opioid Demand via PCA

    Time frame: Postoperative day 1

    Defined as the time elapsed from the patient's arrival in the post-anesthesia care unit (PACU) to the first patient-initiated opioid request via the patient-controlled analgesia (PCA) device.

  5. Extent of Sensory Block

    Time frame: From block administration to 30 minutes post-procedure.

    Sensory block success was evaluated using a 3-point scale via pinprick testing of dermatomes T7 to L1 every 5 minutes after block administration. A successful block was defined as a sensory score ≥1. In all patients, a final dermatomal assessment was performed at the 30th minute to confirm block effectiveness, and the extent of dermatomal spread was documented.

  6. The number of patients who required rescue analgesia.

    Time frame: Postoperative day 1

    The number of patients who required additional IV tramadol due to breakthrough pain (NRS ≥4) despite PCA use.

  7. The patient number of Rescue antiemetic Requirement

    Time frame: Postoperative day 1

    All patients received standard prophylaxis for postoperative nausea and vomiting (PONV), including 8 mg IV dexamethasone before induction and 0.15 mg/kg IV ondansetron (based on ideal body weight) approximately 20 minutes before the end of surgery. PONV was assessed at 0, 3, 6, 12, 18, and 24 hours after extubation using a 5-point scale (0 = no nausea to 4 = multiple episodes of vomiting). Patients with a PONV score ≥3 received rescue treatment with 10 mg IV metoclopramide in 100 mL normal saline via slow infusion. The number of patients requiring rescue antiemetic therapy was recorded.

  8. The number of patients with complications

    Time frame: Postoperative 7 days on an average

    The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded

  9. Mean Arterial Pressure

    Time frame: Postoperative day 1

    Intraoperative mean arterial pressure (MAP) values were recorded at predefined intervals to assess hemodynamic stability.

  10. Heart Rate

    Time frame: Postoperative day 1

    Intraoperative heart rate values were recorded at predefined intervals to assess hemodynamic stability.

  11. Time to First Mobilization

    Time frame: Postoperative day 3

    Defined as the time (in hours) from the end of surgery until the patient is first able to stand and ambulate postoperatively.

  12. Time to First Flatus

    Time frame: Postoperative day 3

    Defined as the time (in hours) from the end of surgery to the first passage of flatus, serving as a clinical marker of return of bowel function.

  13. Time to First Oral Intake

    Time frame: Postoperative day 3

    Defined as the time (in hours) from the end of surgery until the initiation of postoperative oral nutrition.

  14. Length of Hospital Stay

    Time frame: Postoperative day 10

    Defined as the total postoperative hospital stay, measured in days, from the end of surgery until the patient meets institutional discharge criteria and is discharged from the hospital.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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