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

NCT ID: NCT06630858

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-05-01

Brief 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.

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.

Conditions

Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group S-QLB3

S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA

Group Type: ACTIVE_COMPARATOR

Subcostal Anterior Quadratus Lumborum Block

Intervention Type: 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.

Patient Controlled Analgesia (IV PCA)

Intervention Type: 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.

Group ITM

ITM Morphine (a total of 0.2 mg of morphine sulfate + 7.5 mg isobaric (plain) bupivacaine ) + iv morphine-PCA

Group Type: ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type: 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)

Intervention Type: 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.

Interventions

Subcostal Anterior Quadratus Lumborum Block

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.

Intervention Type: PROCEDURE

Intrathecal Morphine

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

Intervention Type: PROCEDURE

Patient Controlled Analgesia (IV PCA)

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Cengiz KAYA

Professor Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cengiz Kaya, MD

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

OndokuzMAyis University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40639953 (View on PubMed)

Other Identifiers

S-QLBITMLSN

Identifier Type: -

Identifier Source: org_study_id