Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

Study Overview
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Brief Summary
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Most of the patients undergoing laparoscopic partial/radical nephrectomy can experience moderate or severe postoperative pain, and inadequate control of this pain can cause negative consequences such as development of chronic pain, pulmonary and cardiac events, and side effects of long term opioid usage. Due to these adverse outcomes, ultrasonography-guided plane blocks can be beneficial for these patients to decrease opioid consumption. In this study, we aim to compare ultrasonography-guided plane blocks: Paravertebral block and subcostal transversus abdominis plane block and traditional method: patient controlled analgesia with opioids. We hypothesized that analgesic efficacy in both paravertebral and subcostal TAP blocks will have similar outcomes but better than traditional method.

Detailed Description
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More than half of patients undergoing laparoscopic partial/radical nephrectomy develop moderate or severe postoperative pain. Inadequate control of postoperative pain may delay early mobilization and rehabilitation, increase pulmonary and thromboembolic events, prolong hospital stay, and decrease patient satisfaction. Inadequate postoperative pain control may lead to the development of chronic pain, resulting in long-term opioid use. In the traditional analgesia model provided with opioids, patients may develop side effects such as nausea, vomiting, hypotension, loss of consciousness, and respiratory depression. For this reason, it would be more rational to provide analgesia with regional methods, which are decided according to the suitability of the patient and the surgical procedure, rather than the use of intravenous drugs. Ultrasonography-guided plane blocks, one of the main elements of multimodal analgesia, are used more frequently with the introduction of ultrasonography into daily practice. These blocks are frequently preferred in daily practice as they reduce opioid consumption by providing effective postoperative analgesia with low complication rates and ease of application. In the ultrasonography-guided paravertebral block, local anesthetic is injected into the triangle constituted by superior costotransvers ligament, parietal pleura and vertebral body where the spinal nerves emerge from the intervertebral foramen. Ipsilateral somatic and sympathetic nerve blockade is observed. It is a body block that can be used to provide both analgesia and anesthesia. Paravertebral block provides successful postoperative analgesia, reduces the decline in postoperative respiratory function, accelerates the recovery of respiratory mechanics, and reduces postoperative vomiting, allowing earlier initiation of oral intake. Ultrasonography-guided subcostal transversus abdominis plane block is a relatively safe and simple body block in which local anesthetic is injected into the fascial plane located between posterior rectus sheath and transversus abdominis muscle. The transversus abdominis plane is the fascial plane superficial to the transversus abdominis muscle, the innermost muscular layer of the anterolateral abdominal wall. The subcostal transversus abdominis plane block ideally anesthetizes the intercostal nerves T6-T9 between the rectus abdominis sheath and the transversus abdominis muscle. It is a truncal block that has drawn attention recently, both because it is easier to apply and because it is a more peripheral block. In this study we aim to compare the effects of two truncal blocks on postoperative pain, morphine consumption, chronic pain and complications.

Official Title
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Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy

Conditions
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Analgesia, Anesthesia, Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacain
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-75 Patients who are ASA (American Society of Anesthesiology): I-II Patients who will have laparoscopic partial/radical nephrectomy Patients who volunteer to participate in the study Exclusion Criteria: Patients with any kind of coagulopathy Patients with severe cardiac, pulmonary, renal or liver disease Patients who have difficulty comprehending the IV PCA device Patients with local anesthetic allergy Patients with chronic opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMISED SINGLE BLINDED INTERVENTIONAL
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral Block Group<br>In this group, preoperative ultrasound-guided paravertebral block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 in the paravertebral space. | Drug: Bupivacain<br>* %0,25<br>* Other names: Marcaine;Drug: Morphine<br>* In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.<br>* Other names: Morphine Sulfate;|
| Active Comparator: Subcostal Transversus Abdominis Plane Block Group<br>In this group, preoperative ultrasound-guided subcostal transversus abdominis plane block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 into the fascial plane between erector spine muscle and transverse process | Drug: Bupivacain<br>* %0,25<br>* Other names: Marcaine;Drug: Morphine<br>* In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.<br>* Other names: Morphine Sulfate;|
| Active Comparator: Intravenous Patient Controlled Analgesia<br>In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method. | Drug: Morphine<br>* In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.<br>* Other names: Morphine Sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Intravenous Total Morphine Consumption | The total dosage of intravenous morphine consumption in 24 hours. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Visual Analog Score (VAS) | A visual analog score (VAS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable | Up to 24 hours | 
| Rescue analgesia administration amounts | Time of postoperative rescue analgesic requirement time. | Up to 24 hours | 
| Incidence of complications due to the regional blocks | Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs. | Up to first week | 
| Chronic postoperative pain | Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day. | Up to 90th day | 
| Lenght of Hospital Stay | Lenght of Hospital Stay | Up to first week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy