AzTrials
AzTrials

AnesthesiaNCT06630858

Intrathecal Morphine vs. Quadratus Lumborum Block for Pain in Laparoscopic Nephrectomy

A study testing Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine in people with Anesthesia and Analgesia, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).

Completed

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

Official record
Search all trials

Trial summary

In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and İntrathecal morphine (ITM) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia, Analgesia, Acute Pain
What is being tested?
Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesTurkey (Türkiye)
Study dates
8 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years who had an American Society of Anesthesiologists (ASA) Physical Status classification I-III

Who cannot join

  • refusal to participate in the study
  • body mass index\>35 kg/m2
  • contraindications to peripheral nerve blocks or spinal anesthesia (e.g., the presence of coagulopathy or pre-existing local or systemic infection etc.)
  • unable to perform regional anesthesia because of anatomical deformity
  • clinically important cardiovascular and cerebrovascular diseases or preexisting significant organ dysfunction (eg, hepatic, renal or respiratory disorders)
  • allergic reaction to any study drugs
Show all 9Show fewer
  • history of substance
  • abuse within the three-month period prior to surgery, chronic opioid use for at least a continuous administration of opioids for a duration of 30 days at daily morphine-equivalent dose ≥15 mg/d (1)
  • psychiatric illness and disorder in communication.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Ondokuz Mayis University

    Samsun, 55139

  • OndokuzMAyis University

    Samsun, 55139

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of The Effects of Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery: A Randomized, Single-Blind, Non-Inferiority Trial

In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and İntrathecal morphine (ITM) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.

Read the detailed description

For all patients undergoing surgery, analgesic medications and techniques are routinely administered preoperatively, intraoperatively, and postoperatively to relieve their pain. Depending on the method applied, patients' analgesic needs in the recovery room and ward after surgery may vary. In patients undergoing laparoscopic nephrectomy, multimodal analgesia (paracetamol, nonsteroidal anti-inflammatory drugs, and opioids) is routinely applied in our clinic, utilizing various regional techniques or intravenous analgesics .

Opioids are the gold standard for postoperative pain control; however, they increase the incidence of opioid-related adverse effects such as dizziness, nausea, vomiting, constipation, and respiratory depression. Therefore, minimizing opioid use and its side effects is essential for postoperative pain control. Regional analgesia is a beneficial method for reducing opioid consumption and postoperative pain. It may also reduce postoperative morbidity and mortality.

Recently, interfascial plane blocks have been used for postoperative pain control in abdominal surgeries. The quadratus lumborum block (QLB) is a relatively new interfascial plane block technique in which local anesthetics are injected adjacent to the quadratus lumborum muscle. There are four different approaches to the QLB: anterior, intramuscular, lateral, and posterior. Anterior QLB involves the injection of a local anesthetic between the quadratus lumborum (QL) muscle and the psoas muscle. The dermatome coverage is determined by the injection site. The injection of local anesthetic anterior to the QL muscle potentially allows the drug to spread into the thoracic paravertebral space, blocking the somatic and sympathetic nerves of the lower thoracic segments. This situation helps us achieve more effective analgesia in abdominal surgeries.

Intrathecal morphine (ITM) is an emerging strategy for postoperative analgesia following major abdominal surgery. Traditional spinal analgesia protocols often rely on continuous thoracic epidural anesthesia due to their ability to provide adequate analgesia with a few cardiopulmonary complications. However, epidural anesthesia is also associated with more frequent perioperative hypotension, technical failures, increased fluid administration, and longer length of stay (LOS). Therefore, ITM is an attractive alternative because it offers easier administration, potent efficacy at low doses, and reduced postoperative complications, providing a form of spinal analgesia that can be used when epidural catheters are contraindicated.

The analgesic properties of ITM have been demonstrated in recent studies involving cardiac, gynecological, spinal, orthopedic, urological, colorectal, hepatopancreatobiliary, and major abdominal surgeries. With an estimated duration of action of up to 24 hours, these studies have focused on the initial postoperative recovery period and generally found lower pain scores and, in some cases, reduced early postoperative opioid requirements. Intrathecal morphine has been successfully used for postoperative pain in various surgeries. Being a hydrophilic opioid, morphine's limited sequestration in adipose tissue delays its clearance from the cerebrospinal fluid compared to other opioids. As a result, the analgesic effects of intrathecal morphine last longer, providing up to 24 hours of analgesia without the need for indwelling catheters or continuous infusions. Direct injection into the intrathecal space also allows morphine to act directly on opioid receptors in the brain and the substantia gelatinosa of the spinal cord, providing a potent analgesic response.

In this study, it was aimed to determine whether the subcostal anterior quadratus lumborum block (S-QLB3) is non-inferior to intrathecal morphine (ITM) in terms of postoperative 24-hour opioid consumption in patients undergoing laparoscopic nephrectomy.

The H0 hypothesis of study is that the mean difference in postoperative 24-hour morphine consumption between S-QLB3 and ITM is less than or equal to the non-inferiority margin.

Patients will be divided into two groups:

Group S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Group ITM: Intrathecal morphine will be performed (5 mcg/kg preservative-free morphine (maximum 200 mcg) + 7.5 mg isobaric bupivacaine). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Being tested
Subcostal Anterior Quadratus Lumborum Block, Intrathecal Morphine, Patient Controlled Analgesia (IV PCA)
Keywords
Subcostal Anterior Quadratus Lumborum Block, Laparoscopic nephrectomy, Intrathecal morphine
Medical subject headings
Agnosia, Acute Pain

What participants receive

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

  • Subcostal Anterior Quadratus Lumborum BlockProcedure or surgery

    S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM.

  • Intrathecal MorphineProcedure or surgery

    Intrathecal morphine will be performed (a total of 0.2 mg of morphine sulfate + 7.5 mg isobaric bupivacaine).

  • Patient Controlled Analgesia (IV PCA)Drug

    IV morphine-PCA will be applied postoperatively for 24 hours . IV-PCA: The requested dose will be 1mg morphine, the lock-in time will be 6 minutes, the 4-hour limit will be 20 mg morphine.

Study groups in NCT06630858
Study groupRoleWhat they receive
Group S-QLB3Active comparatorS-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA
Receives: Procedure: Subcostal Anterior Quadratus Lumborum Block; Drug: Patient Controlled Analgesia (IV PCA)
Group ITMActive comparatorITM Morphine (a total of 0.2 mg of morphine sulfate + 7.5 mg isobaric (plain) bupivacaine ) + iv morphine-PCA
Receives: Procedure: Intrathecal Morphine; Drug: Patient Controlled Analgesia (IV PCA)

What is being measured

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

  1. Cumulative equivalent morphine consumption in the first 24 hours after surgery

    Cumulative equivalent morphine consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4. In cases where rescue analgesia is required (NRS score ≥4), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.

    Measured: postoperative day 1

Secondary outcomes (13)
  1. Postoperative pain scores

    Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, and 24 hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10.

    Measured: postoperative day 1

  2. Patients satisfaction and quality of pain management

    Patientsmanagement satisfaction and quality will be evaluated using the Turkish version of the 15-item quality of recovery (QoR-15) scale (1,2). The QoR-15 is measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale is a patient-perceived, well-validated, global outcome measure of postoperative recovery, and provides an aggregate score ranging from 0 (extremely poor recovery) to 150 (excellent recovery).

    Measured: preoperatively, postoperative day 1 and the 1 day of discharge

  3. intraoperative total remifentanil consumption

    The total amount of remifentanil consumed will be recorded.

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

  4. The heart rate measurement

    The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

    Measured: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes

  5. The mean arterial pressure measurement

    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

    Measured: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.

  6. The number of patients requiring rescue analgesics

    The number of patients requiring rescue analgesics will be recorded over 24 hours.

    Measured: postoperative day 1

  7. Cumulative equivalent morphine consumption in the first 12 hours after surgery

    Cumulative equivalent morphine consumption in the first 12 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4 and 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.

    Measured: postoperative day 1

  8. The number of patients requiring postoperative antiemetics.

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, and 24 hours after extubation. For PONV prophylaxis, patients will be routinely administered 8 mg IV dexamethasone before induction and 0.15 mg/kg (IVA) IV ondansetron 20 minutes before the end of the procedure. If a score of 3 or more is recorded, 4 mg IV ondansetron will be administered and repeated after 4 hours if required. Despite the administration of ondansetron, if the score is ≥3, the patients will be administered 10 mg IV metoclopramide diluted in 100 ml saline solution as an IV infusion. The number of patients who receive antiemetic treatment will be recorded. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

    Measured: postoperative day 1

  9. Sedation score

    Sedation score will be assessed at 0, 3, 6, 12, and 24 hours after extubation. (0: awake, 1: drowsy but easily arousable, 2: very drowsy but still arousable, 3: difficult to rouse)

    Measured: postoperative day 1

  10. Time of first analgesic request

    Time at which the first analgesic is requested

    Measured: postoperative day 1

  11. The morbidity of patients

    The patients comorbidities will be assessed using the Charlson Comorbidity Index.

    Measured: Postoperative 1 month on an average

  12. Complications

    The following complications observed until discharge (30 days) will be recorded: post-dural puncture headache, respiratory depression, nausea, vomiting, itching, sedation, nerve injury, hematoma or infection at the puncture site, visceral organ injury, pneumothorax, retroperitoneal hematoma, quadriceps weakness, and LAST. The severity of observed complications will be assessed using the Clavien-Dindo classification. Additionally, the Comprehensive Complication Index will be used to evaluate the patients overall postoperative morbidity.

    Measured: Postoperative 1 month on an average

  13. The incidences of post-operative pruritus

    The presence and severity of pruritus will be assessed using a four-point scale where 0 indicates no pruritus, 1 indicates mild pruritus, 2 indicates moderate pruritus, and 3 indicates severe pruritus. A score of ≥1 will be considered the presence of pruritus.

    Measured: Postoperative day 1

Timeline

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

  1. First posted8 Oct 2024
  2. Study start8 Oct 2024
  3. Primary completion2 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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program;Research Randomizer (Urbaniak and Plous 2013).
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630858
Sponsor's protocol ID
S-QLBITMLSN
Status last verified
May 2025
First submitted
2 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

  • Kaya C, Dost B, Turunc E, Ustun YB, Kibar AN, Cebeci H, De Cassai A, Elsharkawy H. Unilateral subcostal anterior quadratus lumborum block versus intrathecal morphine for postoperative pain in laparoscopic nephrectomy: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jul 10:rapm-2025-106844. doi: 10.1136/rapm-2025-106844. Online ahead of print.

    PubMed 40639953

Questions about this trial

What is this clinical trial studying?

A study testing Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine in people with Anesthesia and Analgesia, run by Ondokuz Mayıs University at 2 sites 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?

The sponsor lists 1 inclusion and 9 exclusion criteria. 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 2 sites 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 equivalent morphine 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 NCT06630858, 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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in