NCT06653439

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

October 20, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

AnesthesiaNerve blockColorectal surgerySubcostal Anterior Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (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.

    Postoperative day 1

Secondary Outcomes (14)

  • Cumulative opioid consumption in the first 12 hours after surgery

    Postoperative 12 hours.

  • Intraoperative Remifentanil Consumption

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

  • Numerical Rating Scale Assessment of Postoperative Pain

    Postoperative day 1

  • Time to First Opioid Demand via PCA

    Postoperative day 1

  • Extent of Sensory Block

    From block administration to 30 minutes post-procedure.

  • +9 more secondary outcomes

Study Arms (2)

Group S-QLB

ACTIVE COMPARATOR

A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

Procedure: Bilateral ultrasound guided Subcostal Quadratus Lumborum BlockDrug: IV morphine PCA

Group Control

ACTIVE COMPARATOR

IV morphine PCA

Procedure: ControlDrug: IV morphine PCA

Interventions

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.

Also known as: S-QLB group
Group S-QLB
ControlPROCEDURE

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.

Also known as: Control group
Group Control

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.

Also known as: PCA
Group ControlGroup S-QLB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • They will be able to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control GroupsPassive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsSkin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Esra Turunc

    Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Researchers, surgeons and nurses, and those involved in study outcome analysis will not be aware of the randomization of the group. Due to the nature of the intervention, patient blinding was not feasible. Block quality and standardization will be performed by an anesthetist experienced in regional anesthesia for S-QLB block.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A block randomization was performed by an independent physician using a computer-generated sequence via a web-based program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 22, 2024

Study Start

October 28, 2024

Primary Completion

April 20, 2025

Study Completion

May 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations