NCT06075498

Brief Summary

Prostate cancer is the second most common cancer and the fifth in cancer-related deaths. Open radical retropubic prostatectomy is the most common surgical treatment for localized prostate cancer. Open radical retropubic prostatectomy is associated with moderate pain. Severe pain in the postoperative period affects the length of hospital stay and morbidity. Multimodal analgesia applications for the management of postoperative pain are the main component of post-surgical recovery. Different analgesia modalities, including systemic opioid use and neuraxial analgesia, have been used for pain control after retropubic radical prostatectomy. Side effects of systemic and intrathecal opioids limit the potential benefits of these agents. Transversus abdominis plane block and quadratus lumborum block are blocks that can be used for postoperative analgesia in the abdominal and pelvic regions. There is no study in the literature comparing the efficacy of these two blocks for postoperative analgesia in open radical retropubic prostatectomy and their effects on narcotic consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

January 24, 2022

Last Update Submit

April 24, 2024

Conditions

Keywords

quadratus lumborum block, transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • To compare the two groups analgesic efficacy and opioid consumption within 24 hours postoperatively.

    Comparing the analgesic effectiveness of the transversus abdominis plane block and posterior approach quadratus lumborum block and opioid intake and patient pain within 24 hours after surgery

    24 hours postoperatively

Secondary Outcomes (1)

  • Duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.

    24 hours postoperatively

Study Arms (2)

transversus abdominis plane block

ACTIVE COMPARATOR

The group that underwent bilateral transversus abdominis plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

Procedure: transversus abdominis plane block,

quadratus lumborum plane block

ACTIVE COMPARATOR

The group that underwent bilateral quadratus lumborum plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

Procedure: transversus abdominis plane block,

Interventions

2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block

Also known as: quadratus lumborum plane block
quadratus lumborum plane blocktransversus abdominis plane block

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients will be included in the study, as there are patients who underwent prostate surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II-II patients who can adapt to the pain assessment scale will be included in the study.

You may not qualify if:

  • Patients under 18 years of age
  • ASA IV patients
  • patients with known allergy to analgesic drugs
  • patients with any contraindications for the regional technique (patients with coagulation disorders, injection site infection, patients allergic to local anesthetics)
  • patients with chronic analgesic use
  • body mass patients with an index over 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeProstatic Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • basak altiparmak

    Mugla Sitki Kocman University Department of Anesthesia

    STUDY CHAIR
  • ahmet pinarbasi

    Mugla Sitki Kocman University Department of Anesthesia

    STUDY CHAIR
  • ilker akarken

    Mugla sitki kocman department of urology

    STUDY CHAIR
  • bakiye ugur

    Mugla Sitki Kocman Universty of Anaesthesia

    STUDY CHAIR
  • eylem yasar

    Mugla Sitkı Kocman Training and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Postoperative follow-up was evaluated by a research assistant blind to the procedure. groups 1 and 2 were presented to the Outcome Assessor.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: patients who underwent open retropubic prostatectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

January 24, 2022

First Posted

October 10, 2023

Study Start

February 5, 2022

Primary Completion

May 21, 2023

Study Completion

June 21, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Only the IPD (after the unidentification of the patients) will be available by correspondence author e-mail.

Locations