Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

NCT ID: NCT05943015

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-12-15

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Quadratus Lumborum Block II

Quadratus Lumborum Block II

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Block II

Intervention Type: 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.

Patient controlled intravenous analgesia

Intervention Type: 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 III

Quadratus Lumborum Block III

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Block III

Intervention Type: 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.

Patient controlled intravenous analgesia

Intervention Type: 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

Paravertebral Block

Paravertebral Block

Group Type: ACTIVE_COMPARATOR

Paravertebral Block

Intervention Type: 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.

Patient controlled intravenous analgesia

Intervention Type: 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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMINE KOSE

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

DONDU GENC MORALAR

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

SERPIL SAHIN SEHIRLIOGLU

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

Locations

Gaziosmanpasa Resarch and Education Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 36891030 (View on PubMed)

Other Identifiers

GaziosmanpasaTREHEK

Identifier Type: -

Identifier Source: org_study_id