Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

NCT05943015 | Completed

• 1 other identifier: GaziosmanpasaTREHEK
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

paravertebral block; quadratus lumborum block; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Visual Analogue Scale values at 1st, 6th, 12th and 24th hours

  at 1st, 6th, 12th and 24th hours after the surgery

• Block onset time

  30 min after the block

• intraoperative remifentanil consumption

  during operation procedure

• postoperative length of hospital stay

  within 1 weeks after the surgery

• side effects such as nausea, vomiting and shoulder pain

  within 24 hours after the surgery

Study Arms (3)

Quadratus Lumborum Block II

ACTIVE COMPARATOR

Quadratus Lumborum Block II

Procedure: Quadratus Lumborum Block II; Drug: Patient controlled intravenous analgesia

Quadratus Lumborum Block III

ACTIVE COMPARATOR

Quadratus Lumborum Block III

Procedure: Quadratus Lumborum Block III; Drug: Patient controlled intravenous analgesia

Paravertebral Block

ACTIVE COMPARATOR

Paravertebral Block

Procedure: Paravertebral Block; Drug: Patient controlled intravenous analgesia

Interventions

Quadratus Lumborum Block II PROCEDURE

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.

Quadratus Lumborum Block II

Patient controlled intravenous analgesia DRUG

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

Quadratus Lumborum Block II

Quadratus Lumborum Block III PROCEDURE

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.

Quadratus Lumborum Block III

Paravertebral Block PROCEDURE

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.

Paravertebral Block

Eligibility Criteria

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

You may qualify if:

• years, American Society of Anesthesiologists physical statusⅠ-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Resarch and Education Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36891030 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 12, 2023
• Study Start: September 5, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: July 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)