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AnesthesiaNCT06653439

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

A study testing Bilateral ultrasound guided Subcostal Quadratus Lumborum Block and IV morphine PCA in people with Anesthesia and Regional Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bilateral ultrasound guided Subcostal Quadratus Lumborum Block and IV morphine PCA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Oct 2024to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ondokuz Mayis University

    Samsun, 55139

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Bilateral ultrasound guided Subcostal Quadratus Lumborum Block, Control, IV morphine PCA
Keywords
Anesthesia, Nerve block, Colorectal surgery, Subcostal Anterior Quadratus Lumborum Block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral ultrasound guided Subcostal Quadratus Lumborum BlockProcedure or surgery

    Also called S-QLB group

    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.

  • ControlProcedure or surgery

    Also called Control group

    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.

  • IV morphine PCADrug

    Also called PCA

    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.

Study groups in NCT06653439
Study groupRoleWhat they receive
Group S-QLBActive comparatorA bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)
Receives: Procedure: Bilateral ultrasound guided Subcostal Quadratus Lumborum Block; Drug: IV morphine PCA
Group ControlActive comparatorIV morphine PCA
Receives: Procedure: Control; Drug: IV morphine PCA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative opioid consumption in the first 24 hours after surgery

    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.

    Measured: Postoperative day 1

Secondary outcomes (14)
  1. Cumulative opioid consumption in the first 12 hours after surgery

    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.

    Measured: Postoperative 12 hours.

  2. Intraoperative Remifentanil Consumption

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

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

  3. Numerical Rating Scale Assessment of Postoperative Pain

    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.

    Measured: Postoperative day 1

  4. Time to First Opioid Demand via PCA

    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.

    Measured: Postoperative day 1

  5. Extent of Sensory Block

    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.

    Measured: From block administration to 30 minutes post-procedure.

  6. The number of patients who required rescue analgesia.

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

    Measured: Postoperative day 1

  7. The patient number of Rescue antiemetic Requirement

    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.

    Measured: Postoperative day 1

  8. The number of patients with complications

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

    Measured: Postoperative 7 days on an average

  9. Mean Arterial Pressure

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

    Measured: Postoperative day 1

  10. Heart Rate

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

    Measured: Postoperative day 1

  11. Time to First Mobilization

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

    Measured: Postoperative day 3

  12. Time to First Flatus

    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.

    Measured: Postoperative day 3

  13. Time to First Oral Intake

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

    Measured: Postoperative day 3

  14. Length of Hospital Stay

    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.

    Measured: Postoperative day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start28 Oct 2024
  3. Primary completion20 Apr 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A block randomization was performed by an independent physician using a computer-generated sequence via a web-based program.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653439
Sponsor's protocol ID
SQLB3CRS
Status last verified
Jun 2025
First submitted
20 Oct 2024
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Turunc E, Dost B, Kaya C, Ustun YB, Bilgin S, Ozdemir E, Koksal E, De Cassai A, Elsharkawy H. Efficacy of anterior subcostal quadratus lumborum block for postoperative analgesia in laparoscopic colorectal surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Oct 28:rapm-2025-107136. doi: 10.1136/rapm-2025-107136. Online ahead of print.

    PubMed 41151981

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral ultrasound guided Subcostal Quadratus Lumborum Block and IV morphine PCA in people with Anesthesia and Regional Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative opioid consumption in the first 24 hours after surgery (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06653439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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