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Clinical Trials/NCT05723341
NCT05723341
Completed
Not Applicable

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

Istanbul University1 site in 1 country91 target enrollmentFebruary 15, 2023

Overview

Phase
Not Applicable
Intervention
Bupivacain
Conditions
Analgesia
Sponsor
Istanbul University
Enrollment
91
Locations
1
Primary Endpoint
Postoperative Intravenous Total Morphine Consumption
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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, the investigators aim to compare ultrasonography-guided plane blocks: Paravertebral block and subcostal transversus abdominis plane block and traditional method: patient controlled analgesia with opioids. The investigators hypothesized that analgesic efficacy in both paravertebral and subcostal TAP blocks will have similar outcomes but better than traditional method.

Detailed Description

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 the investigators aim to compare the effects of two truncal blocks on postoperative pain, morphine consumption, chronic pain and complications.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Savran Karadeniz

Associate professor

Istanbul University

Eligibility Criteria

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

Arms & Interventions

Paravertebral Block Group

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.

Intervention: Bupivacain

Paravertebral Block Group

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.

Intervention: Morphine

Subcostal Transversus Abdominis Plane Block Group

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

Intervention: Bupivacain

Subcostal Transversus Abdominis Plane Block Group

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

Intervention: Morphine

Intravenous Patient Controlled Analgesia

In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.

Intervention: Morphine

Outcomes

Primary Outcomes

Postoperative Intravenous Total Morphine Consumption

Time Frame: Up to 24 hours

The total dosage of intravenous morphine consumption in 24 hours.

Secondary Outcomes

  • Rescue analgesia administration amounts(Up to 24 hours)
  • Incidence of complications due to the regional blocks(Up to first week)
  • Chronic postoperative pain(Up to 90th day)
  • Lenght of Hospital Stay(Up to first week)
  • Postoperative Visual Analog Score (VAS)(Up to 24 hours)

Study Sites (1)

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