NCT03606889

Brief Summary

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

3.4 years

First QC Date

July 11, 2018

Last Update Submit

June 2, 2022

Conditions

Prostatic CancerPain, PostoperativePainAnesthetics, Local

Outcome Measures

Primary Outcomes (1)

  • Total oxycodone used in the first 24 hours after surgery

    Total cumulative oxycodone dose in mg used in the first 24 hours after surgery

    24 hours

Secondary Outcomes (1)

  • Severity of postoperative pain via visual analogue pain scale (VAS)

    24 hours

Study Arms (2)

Quadratus Lumborum block group

EXPERIMENTAL

Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Diagnostic Test: Quadratus Lumborum blockDrug: Bupivacaine

Transversus abdominis plane block group

EXPERIMENTAL

Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%

Diagnostic Test: Tranversus Abdominis plane blockDrug: Bupivacaine

Interventions

Quadratus Lumborum blockDIAGNOSTIC_TEST

0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle

Also known as: QLB
Quadratus Lumborum block group
Tranversus Abdominis plane blockDIAGNOSTIC_TEST

0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.

Also known as: TAP
Transversus abdominis plane block group
BupivacaineDRUG

0.2 ml/kg bupivicaine

Quadratus Lumborum block groupTransversus abdominis plane block group

Eligibility Criteria

Age18 Years - 90 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate is only in males.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pateints who will have prostatectomy ASA II or III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital in Cracow

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Prostatic NeoplasmsPain, PostoperativePain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Tomasz Skladzien, MD PHD

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PHD

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 31, 2018

Study Start

July 31, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

PL(1)