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

Primary Purpose

Analgesia, Anesthesia, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacain
Morphine
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Paravertebral Block Group

Subcostal Transversus Abdominis Plane Block Group

Intravenous Patient Controlled Analgesia

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Postoperative Intravenous Total Morphine Consumption
The total dosage of intravenous morphine consumption in 24 hours.

Secondary Outcome Measures

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
Rescue analgesia administration amounts
Time of postoperative rescue analgesic requirement time.
Incidence of complications due to the regional blocks
Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.
Chronic postoperative pain
Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.
Lenght of Hospital Stay
Lenght of Hospital Stay

Full Information

First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05723341
Brief Title
Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy
Official Title
Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Anesthesia, Pain, Postoperative
Keywords
Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMISED SINGLE BLINDED INTERVENTIONAL
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral Block Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subcostal Transversus Abdominis Plane Block Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intravenous Patient Controlled Analgesia
Arm Type
Active Comparator
Arm Description
In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
Marcaine
Intervention Description
%0,25
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
Primary Outcome Measure Information:
Title
Postoperative Intravenous Total Morphine Consumption
Description
The total dosage of intravenous morphine consumption in 24 hours.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Postoperative Visual Analog Score (VAS)
Description
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
Time Frame
Up to 24 hours
Title
Rescue analgesia administration amounts
Description
Time of postoperative rescue analgesic requirement time.
Time Frame
Up to 24 hours
Title
Incidence of complications due to the regional blocks
Description
Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.
Time Frame
Up to first week
Title
Chronic postoperative pain
Description
Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.
Time Frame
Up to 90th day
Title
Lenght of Hospital Stay
Description
Lenght of Hospital Stay
Time Frame
Up to first week
Other Pre-specified Outcome Measures:
Title
Indidence of PONV (postoperative nausea and vomiting)
Description
Incidence of postoperative nausea and vomiting
Time Frame
Up to 24 hours
Title
Respiratuar Depression
Description
Incidence of respiratory depression due to iv orphine in the postoperative follow-up.
Time Frame
Up to 24 hours
Title
Postoperative Ramsay Sedation Scale (RSS)
Description
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.
Time Frame
Up to 24 hours
Title
Itching
Description
Incidence of itching due to iv morphine in the postoperative follow-up.
Time Frame
Up to 24 hours
Title
Surgeon Satisfaction
Description
Satisfaction score, 0: very unsatisfied 3: very unsatisfied.
Time Frame
Up to 24 hours
Title
Patient Satisfaction
Description
Satisfaction score, 0: very unsatisfied 3: very unsatisfied.
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Savran Karadeniz, MD
Phone
+905334845563
Email
mskaradeniz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gül Cansever, MD
Phone
+905394696304
Email
cnsvr.gul@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, MD
Organizational Affiliation
Istanbul Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27733219
Citation
Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4.
Results Reference
background
PubMed Identifier
8482238
Citation
Schwarz F, Preusler W, Reifart N, Storger H, Hofmann M, Holscher I. [The long-term success after coronary angioplasty in old age]. Dtsch Med Wochenschr. 1993 Apr 30;118(17):609-14. doi: 10.1055/s-2008-1059369. German.
Results Reference
background
PubMed Identifier
28731925
Citation
Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673.
Results Reference
background
PubMed Identifier
23717232
Citation
Parikh BK, Waghmare VT, Shah VR, Mehta T, Butala BP, Parikh GP, Vora KS. The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study. Saudi J Anaesth. 2013 Jan;7(1):43-7. doi: 10.4103/1658-354X.109808.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/27733219/
Description
Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial
URL
https://pubmed.ncbi.nlm.nih.gov/18482238/
Description
Single injection paravertebral block for renal surgery in children
URL
https://pubmed.ncbi.nlm.nih.gov/28731925/
Description
Thoracic paravertebral block for postoperative pain management after renal surgery A randomised controlled trial
URL
https://pubmed.ncbi.nlm.nih.gov/23717232/
Description
The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study

Learn more about this trial

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

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