- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653439
Analgesic Effect of Bilateral Subcostal Quadratus Lumborum Block in Laparoscopic Colorectal Surgery
Analgesic Effect of Ultrasound-Guided Bilateral Subcostal Anterior Quadratus Lumborum Block in Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Postoperative pain management is a critical factor in enhancing recovery and ambulation following laparoscopic colorectal surgery. Effective analgesia is necessary to reduce complications, improve patient comfort, and shorten hospital stays. In this context, multimodal analgesia is a commonly used strategy that combines various analgesic drugs, such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids, to manage pain more effectively by targeting different pathways.
Although opioids are considered the gold standard for postoperative pain control, their use is associated with several undesirable side effects, including nausea, vomiting, dizziness, constipation, and respiratory depression. These opioid-related complications can delay recovery, increase patient discomfort, and extend hospital stays. Therefore, minimizing opioid consumption while still providing effective pain relief is a primary goal in postoperative pain management, particularly for surgeries such as laparoscopic colorectal procedures.
To achieve this goal, regional anesthesia techniques have gained increasing popularity. These techniques, such as interfascial plane blocks, have the potential to reduce opioid use and improve pain control by targeting specific nerve pathways. One of the more recent approaches is the quadratus lumborum block (QLB), which involves the injection of local anesthetics near the quadratus lumborum muscle. This block is particularly useful in abdominal surgeries because it can provide pain relief by affecting both somatic and sympathetic nerves, leading to broader and more effective pain coverage.
The QLB has four different approaches: anterior, lateral, posterior, and intramuscular. The anterior QLB is of particular interest in this setting because it involves the injection of local anesthetic between the quadratus lumborum and psoas muscles, potentially allowing the anesthetic to spread into the thoracic paravertebral space. This spread could result in the blockade of both the somatic nerves and the thoracic sympathetic chain, offering more comprehensive pain relief that is beneficial for abdominal surgeries like colorectal procedures.
The potential advantages of the anterior QLB in laparoscopic colorectal surgery include reduced postoperative pain, decreased opioid consumption, and fewer opioid-related side effects. Additionally, regional anesthesia techniques like QLB may reduce postoperative complications, including respiratory issues, which are particularly important in abdominal surgeries that involve the diaphragm and lower thoracic nerves.
In this study, the hypothesis is that bilateral subcostal anterior QLB, administered during laparoscopic colorectal surgery, will significantly reduce both postoperative pain and the need for opioids.
The aim of this study is to investigate the effects of Bilateral subcostal anterior QLB on postoperative acute pain scores (0-24 hours) and 24- hour opioid consumption in patients who underwent laparoscopic colorectal surgery. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, parallel-group study.
Patients will be divided into two groups:
Group S-QLB:
A bilateral S-QLB (20 ml 0.25% bupivacaine + 1:400.000 adrenaline, bilaterally) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Group Control :
IV morphine-PCA will be applied postoperatively for 24 hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey, 55139
- Ondokuz Mayis University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria They will be aged between 18 and 75 years. They will have an American Society of Anesthesiologists (ASA) physical status classification of I to III.
They will be able to provide written informed consent.
Exclusion Criteria They will refuse to participate. They will have a body mass index (BMI) greater than 35 kg/m². They will have contraindications to peripheral nerve blocks (e.g., coagulopathy, abnormal INR, thrombocytopenia, local or systemic infection).
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Control
IV morphine PCA
|
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Group S-QLB
A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative opioid consumption in the first 24 hours after surgery
Time Frame: Postoperative day 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of patients with complications
Time Frame: Postoperative 7 days on an average
|
The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
|
Postoperative 7 days on an average
|
|
Cumulative opioid consumption in the first 12 hours after surgery
Time Frame: Postoperative 12 hours.
|
The secondary outcome will be defined as cumulative opioid consumption during the first 12 hours following surgery, calculated in intravenous morphine milligram equivalents (IV-MME).
This will include both PCA-administered morphine and rescue intravenous tramadol, in accordance with the standardized ESAIC conversion guidelines.
Patients may request opioids using a PCA device when their NRS score is ≥ 4.
|
Postoperative 12 hours.
|
|
Intraoperative 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.
|
Total intraoperative remifentanil consumption will be recorded in micrograms (µg) from the start of anesthesia induction until the end of surgery.
|
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
Time Frame: Postoperative day 1
|
Pain scores will be assessed using the 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 represents the worst imaginable pain.
Evaluations will be performed both at rest (static) and during coughing or deep breathing (dynamic).
Assessments will be conducted in the post-anesthesia care unit (PACU) after extubation and once communication is established, and subsequently at 3, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative day 1
|
|
Time to First Opioid Demand via PCA
Time Frame: Postoperative day 1
|
Defined as the time elapsed from the patient's arrival in the post-anesthesia care unit (PACU) to the first patient-initiated opioid request via the patient-controlled analgesia (PCA) device.
|
Postoperative day 1
|
|
Extent of Sensory Block
Time Frame: From block administration to 30 minutes post-procedure.
|
Sensory block success was evaluated using a 3-point scale via pinprick testing of dermatomes T7 to L1 every 5 minutes after block administration.
A successful block was defined as a sensory score ≥1.
In all patients, a final dermatomal assessment was performed at the 30th minute to confirm block effectiveness, and the extent of dermatomal spread was documented.
|
From block administration to 30 minutes post-procedure.
|
|
The number of patients who required rescue analgesia.
Time Frame: Postoperative day 1
|
The number of patients who required additional IV tramadol due to breakthrough pain (NRS ≥4) despite PCA use.
|
Postoperative day 1
|
|
The patient number of Rescue antiemetic Requirement
Time Frame: Postoperative day 1
|
All patients received standard prophylaxis for postoperative nausea and vomiting (PONV), including 8 mg IV dexamethasone before induction and 0.15 mg/kg IV ondansetron (based on ideal body weight) approximately 20 minutes before the end of surgery.
PONV was assessed at 0, 3, 6, 12, 18, and 24 hours after extubation using a 5-point scale (0 = no nausea to 4 = multiple episodes of vomiting).
Patients with a PONV score ≥3 received rescue treatment with 10 mg IV metoclopramide in 100 mL normal saline via slow infusion.
The number of patients requiring rescue antiemetic therapy was recorded.
|
Postoperative day 1
|
|
Mean Arterial Pressure
Time Frame: Postoperative day 1
|
Intraoperative mean arterial pressure (MAP) values were recorded at predefined intervals to assess hemodynamic stability.
|
Postoperative day 1
|
|
Heart Rate
Time Frame: Postoperative day 1
|
Intraoperative heart rate values were recorded at predefined intervals to assess hemodynamic stability.
|
Postoperative day 1
|
|
Time to First Mobilization
Time Frame: Postoperative day 3
|
Defined as the time (in hours) from the end of surgery until the patient is first able to stand and ambulate postoperatively.
|
Postoperative day 3
|
|
Time to First Flatus
Time Frame: Postoperative day 3
|
Defined as the time (in hours) from the end of surgery to the first passage of flatus, serving as a clinical marker of return of bowel function.
|
Postoperative day 3
|
|
Time to First Oral Intake
Time Frame: Postoperative day 3
|
Defined as the time (in hours) from the end of surgery until the initiation of postoperative oral nutrition.
|
Postoperative day 3
|
|
Length of Hospital Stay
Time Frame: Postoperative day 10
|
Defined as the total postoperative hospital stay, measured in days, from the end of surgery until the patient meets institutional discharge criteria and is discharged from the hospital.
|
Postoperative day 10
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Turunc, Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SQLB3CRS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University Health Network, TorontoActive, not recruiting
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
Ankara City Hospital BilkentCompletedAnesthesia | Sedation | Anesthesia, Intravenous | Sedation Complication | Recovery From Anesthesia | Monitoring of Depth of AnesthesiaTurkey (Türkiye)
-
Children's Hospital Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingAnesthesia | Anesthesia; ReactionUnited States
Clinical Trials on Bilateral ultrasound guided Subcostal Quadratus Lumborum Block
-
Zagazig UniversityCompletedLaparoscopic Cholecystectomy | Erector Spinae Plane Block | Quadratus Lumborum BlockEgypt
-
Ain Shams UniversityActive, not recruiting
-
Medipol UniversityProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization; Biruni...RecruitingPostoperative Pain | CryptorchidismTurkey (Türkiye)
-
Uludag UniversityCompleted
-
Wael Sayed El GharabawyNot yet recruitingSatisfaction | Pain Management After SurgeryEgypt
-
University of Tennessee Graduate School of MedicineRecruitingPerioperative Opioid Sparing TechniquesUnited States
-
Cairo UniversityRecruitingDevelopmental Dysplasia of the HipEgypt
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedPostoperative Pain | Cesarean Section Complications | Patient Satisfaction | BlockTurkey