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

March 8, 2024 updated by: Meltem Savran Karadeniz, Istanbul University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Bupivacain
%0,25
Other Names:
  • Marcaine
Drug: Morphine
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
Other Names:
  • Morphine Sulfate
Active Comparator: 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
Drug: Bupivacain
%0,25
Other Names:
  • Marcaine
Drug: Morphine
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
Other Names:
  • Morphine Sulfate
Active Comparator: Intravenous Patient Controlled Analgesia
In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.
Drug: Morphine
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
Other Names:
  • Morphine Sulfate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Intravenous Total Morphine Consumption
Time Frame: Up to 24 hours
The total dosage of intravenous morphine consumption in 24 hours.
Up to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Visual Analog Score (VAS)
Time Frame: Up to 24 hours
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 Frame: Up to 24 hours
Time of postoperative rescue analgesic requirement time.
Up to 24 hours
Incidence of complications due to the regional blocks
Time Frame: Up to first week
Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.
Up to first week
Chronic postoperative pain
Time Frame: Up to 90th day
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
Time Frame: Up to first week
Lenght of Hospital Stay
Up to first week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Indidence of PONV (postoperative nausea and vomiting)
Time Frame: Up to 24 hours
Incidence of postoperative nausea and vomiting
Up to 24 hours
Respiratuar Depression
Time Frame: Up to 24 hours
Incidence of respiratory depression due to iv orphine in the postoperative follow-up.
Up to 24 hours
Postoperative Ramsay Sedation Scale (RSS)
Time Frame: Up to 24 hours
Ramsay sedation scale requires the patient to rate their sedation on a defined scale. For example, 1: anxious and agitated or restless, or both 2: cooperative, oriented and tranquil 3: responds to commands only 4: brisk response to stimulus 5: sluggish response to stimulus 6: no response to stimulus.
Up to 24 hours
Itching
Time Frame: Up to 24 hours
Incidence of itching due to iv morphine in the postoperative follow-up.
Up to 24 hours
Surgeon Satisfaction
Time Frame: Up to 24 hours
Satisfaction score, 0: very unsatisfied 3: very unsatisfied.
Up to 24 hours
Patient Satisfaction
Time Frame: Up to 24 hours
Satisfaction score, 0: very unsatisfied 3: very unsatisfied.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meltem Savran Karadeniz, MD, Istanbul Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1276671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Bupivacain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings