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

NCT05723341 | Completed

• 1 other identifier: 2022-1276671
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Anesthesia; Pain, Postoperative

Keywords

Paravertebral Block; Subcostal Transversus Abdominis Plane Block; Postoperative Controlled Analgesia; Postoperative Pain; Laparoscopic Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative Intravenous Total Morphine Consumption

  The total dosage of intravenous morphine consumption in 24 hours.

  Up to 24 hours

Secondary Outcomes (5)

• Postoperative Visual Analog Score (VAS)

  Up to 24 hours

• 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

Other Outcomes (6)

• Indidence of PONV (postoperative nausea and vomiting)

  Up to 24 hours

• Respiratuar Depression

  Up to 24 hours

• Postoperative Ramsay Sedation Scale (RSS)

  Up to 24 hours

Study Arms (3)

Paravertebral Block Group

ACTIVE COMPARATOR

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; Drug: Morphine

Subcostal Transversus Abdominis Plane Block Group

ACTIVE COMPARATOR

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; Drug: Morphine

Intravenous Patient Controlled Analgesia

ACTIVE COMPARATOR

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

Drug: Morphine

Interventions

Bupivacain DRUG

%0,25

Also known as: Marcaine

Paravertebral Block Group; Subcostal Transversus Abdominis Plane Block Group

Morphine DRUG

In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.

Also known as: Morphine Sulfate

Intravenous Patient Controlled Analgesia; Paravertebral Block Group; Subcostal Transversus Abdominis Plane Block Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27733219 BACKGROUND

• 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.

  PMID: 8482238 BACKGROUND

• 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.

  PMID: 28731925 BACKGROUND

• 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.

  PMID: 23717232 BACKGROUND

Related Links

• Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial
• Single injection paravertebral block for renal surgery in children
• Thoracic paravertebral block for postoperative pain management after renal surgery A randomised controlled trial
• The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Meltem Savran Karadeniz, MD

  Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: RANDOMISED SINGLE BLINDED INTERVENTIONAL

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 10, 2023
• Study Start: February 15, 2023
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)