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Completed

NCT Number: NCT06630858

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University, Samsun, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Subcostal Anterior Quadratus Lumborum Block

Procedure

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 Morphine

Procedure

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.

Primary outcomes

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

    Time frame: postoperative day 1

    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.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: postoperative day 1

    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.

  2. Patients satisfaction and quality of pain management

    Time frame: preoperatively, postoperative day 1 and the 1 day of discharge

    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).

  3. intraoperative total 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.

    The total amount of remifentanil consumed will be recorded.

  4. The heart rate measurement

    Time frame: 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

    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.

  5. The mean arterial pressure measurement

    Time frame: 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.

    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.

  6. The number of patients requiring rescue analgesics

    Time frame: postoperative day 1

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

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

    Time frame: postoperative day 1

    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.

  8. The number of patients requiring postoperative antiemetics.

    Time frame: postoperative day 1

    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.

  9. Sedation score

    Time frame: postoperative day 1

    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)

  10. Time of first analgesic request

    Time frame: postoperative day 1

    Time at which the first analgesic is requested

  11. The morbidity of patients

    Time frame: Postoperative 1 month on an average

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

  12. Complications

    Time frame: Postoperative 1 month on an average

    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.

  13. The incidences of post-operative pruritus

    Time frame: Postoperative day 1

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 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.

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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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