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

NCT06630858 | Completed

• 1 other identifier: S-QLBITMLSN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Keywords

Subcostal Anterior Quadratus Lumborum Block; Laparoscopic nephrectomy; Intrathecal morphine

Outcome Measures

Primary Outcomes (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.

  postoperative day 1

Secondary Outcomes (13)

• Postoperative pain scores

  postoperative day 1

• Patients satisfaction and quality of pain management

  preoperatively, postoperative day 1 and the 1 day of discharge

• intraoperative total remifentanil consumption

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

• 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, up to 180 minutes

• 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, up to 180 minutes.

Study Arms (2)

Group S-QLB3

ACTIVE COMPARATOR

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

Procedure: Subcostal Anterior Quadratus Lumborum Block; Drug: Patient Controlled Analgesia (IV PCA)

Group ITM

ACTIVE COMPARATOR

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

Procedure: Intrathecal Morphine; Drug: Patient Controlled Analgesia (IV PCA)

Interventions

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.

Group S-QLB3

Intrathecal Morphine PROCEDURE

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

Group ITM

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.

Group ITM; Group S-QLB3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

Location

OndokuzMAyis University

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40639953 DERIVED

MeSH Terms

Conditions

Agnosia; Acute Pain

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Cengiz Kaya, MD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based;Research Randomizer; (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: 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).

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: October 8, 2024
• Primary Completion: April 2, 2025
• Study Completion: May 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)