search
Back to results

Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia

Primary Purpose

Prostatic Cancer, Pain, Postoperative, Pain

Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Quadratus Lumborum block
Tranversus Abdominis plane block
Bupivacaine
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pateints who will have prostatectomy ASA II or III

Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia

-

Sites / Locations

  • University Hospital in Cracow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Quadratus Lumborum block group

Transversus abdominis plane block group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Severity of postoperative pain via visual analogue pain scale (VAS)
VAS range from 0 for no pain to 10 for worst pain imaginable

Full Information

First Posted
July 11, 2018
Last Updated
June 2, 2022
Sponsor
Jagiellonian University
search

1. Study Identification

Unique Protocol Identification Number
NCT03606889
Brief Title
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
Official Title
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough participants
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian 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
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.
Detailed Description
In laparoscopic prostatectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic prostatectomy may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer, Pain, Postoperative, Pain, Anesthetics, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum block group
Arm Type
Experimental
Arm Description
Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Arm Title
Transversus abdominis plane block group
Arm Type
Experimental
Arm Description
Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%
Intervention Type
Diagnostic Test
Intervention Name(s)
Quadratus Lumborum block
Other Intervention Name(s)
QLB
Intervention Description
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Intervention Type
Diagnostic Test
Intervention Name(s)
Tranversus Abdominis plane block
Other Intervention Name(s)
TAP
Intervention Description
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.2 ml/kg bupivicaine
Primary Outcome Measure Information:
Title
Total oxycodone used in the first 24 hours after surgery
Description
Total cumulative oxycodone dose in mg used in the first 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Severity of postoperative pain via visual analogue pain scale (VAS)
Description
VAS range from 0 for no pain to 10 for worst pain imaginable
Time Frame
24 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate is only in males.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pateints who will have prostatectomy ASA II or III Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Skladzien, MD PHD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital in Cracow
City
Kraków
ZIP/Postal Code
31-501
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia

We'll reach out to this number within 24 hrs