Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral Blocks in Elective Laparoscopic Cholecystectomies

This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Quadratus Lumborum Block II; Drug: Patient controlled intravenous analgesia; Procedure: Quadratus Lumborum Block III; Procedure: Paravertebral Block

Detailed Description

Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.

The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DONDU GENC MORALAR; Phone Number: +905053737913; Email: dondugencm@gmail.com
• Study Contact Backup: Name: EMINE KOSE; Phone Number: +905422748184; Email: emine.kose.184@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Recruiting
    • Gaziosmanpasa Resarch and Education Hospital
    • Contact: DONDU GENC MORALAR; Phone Number: +905053737913; Email: dondugencm@gmail.com
    • Principal Investigator: EMINE KOSE
    • Principal Investigator: DONDU GENC MORALAR
    • Principal Investigator: SERPIL SAHIN SEHIRLIOGLU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years, American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

• local anesthetic allergy
• Infection at the procedure site
• Body Mass Index >35 kg/m2
• Anticoagulant use with bleeding disorder
• Chronic analgesia and opioid use
• with mental and psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum Block II	Procedure: Quadratus Lumborum Block II; Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the psoas major and the transverse process adjacent to the quadratus lumborum muscle, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle negative aspiration into the middle layer of the thoracolumbar fascia posterior to the quadratus lumborum muscle, then 0.5-1 ml of saline 20 ml of 0.25% bupivacaine will be injected after hydrodissection is observed. The same will be done to the other side.; Drug: Patient controlled intravenous analgesia; Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Active Comparator: Quadratus Lumborum Block III	Drug: Patient controlled intravenous analgesia; Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg; Procedure: Quadratus Lumborum Block III; Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Active Comparator: Paravertebral Block	Drug: Patient controlled intravenous analgesia; Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg; Procedure: Paravertebral Block; Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. The linear ultrasound probe is placed longitudinally at the T6 level, 2-2.5 cm lateral to the spinous processes. Transverse process, superior costotransverse ligament and pleura are visualized, 22 gauge 80 mm peripheral block needle is passed with in-plane technique, superior costotransverse ligament is passed, negative aspiration into the paravertebral space under the ligament, followed by 0.5-1 ml of saline and hydrodissection of the pleura, followed by 20 ml of 0.25% bupivacaine is injected.The same is done to the opposite side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of tramadol use	The total tramadol use of the patients in 24 hours will be recorded.	within 24 hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale values at 1st, 6th, 12th and 24th hours	Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.	at 1st, 6th, 12th and 24th hours after the surgery
Block onset time	In order to evaluate sensory block, dermatome involvement will be evaluated with ice between Thoracic 1 and Lumbar 5 levels. When the feeling of coldness disappears, dermatome involvement will be considered. The sensory block formation time with ice will be evaluated as the block onset time, the10th, 20th and 30th minute dermatome area involvement will be recorded.	30 min after the block
intraoperative remifentanil consumption	The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.	during operation procedure
postoperative length of hospital stay	time to patient's discharge	within 1 weeks after the surgery
side effects such as nausea, vomiting and shoulder pain	The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.	within 24 hours after the surgery

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: EMINE KOSE, Gaziosmanpasa Research and Education Hospital; Principal Investigator: DONDU GENC MORALAR, Gaziosmanpasa Research and Education Hospital; Principal Investigator: SERPIL SAHIN SEHIRLIOGLU, Gaziosmanpasa Research and Education Hospital

Publications and helpful links

General Publications

• Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; quadratus lumborum block; paravertebral block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: GaziosmanpasaTREHEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No