Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Quadratus Lumborum Block II
* Drug: Patient controlled intravenous analgesia
* Procedure: Quadratus Lumborum Block III
* Drug: Patient controlled intravenous analgesia
* Procedure: Paravertebral Block
* Drug: Patient controlled intravenous analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum Block II<br>Quadratus Lumborum Block II | Procedure: Quadratus Lumborum Block II<br>* 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.<br>Drug: Patient controlled intravenous analgesia<br>* 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<br>|
| Active Comparator: Quadratus Lumborum Block III<br>Quadratus Lumborum Block III | Procedure: Quadratus Lumborum Block III<br>* 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.<br>Drug: Patient controlled intravenous analgesia<br>* 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<br>|
| Active Comparator: Paravertebral Block<br>Paravertebral Block | Procedure: Paravertebral Block<br>* 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.<br>Drug: Patient controlled intravenous analgesia<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paravertebral block, quadratus lumborum block, laparoscopic cholecystectomy