Prostatic CancerNCT03606889
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
A study testing Quadratus Lumborum block, Tranversus Abdominis plane block and Bupivacaine in people with Prostatic Cancer and Pain, Postoperative, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostatic Cancer, Pain, Postoperative, Pain
- What is being tested?
- Quadratus Lumborum block, Tranversus Abdominis plane block and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jul 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prostatic Cancer, Pain, Postoperative, Pain, Anesthetics, Local
- Being tested
- Quadratus Lumborum block, Tranversus Abdominis plane block, Bupivacaine
- Medical subject headings
- Prostatic Neoplasms, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum blockDiagnostic test
Also called QLB
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Tranversus Abdominis plane blockDiagnostic test
Also called TAP
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
BupivacaineDrug
0.2 ml/kg bupivicaine
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum block group | Experimental | Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125% Receives: Diagnostic Test: Quadratus Lumborum block; Drug: Bupivacaine |
| Transversus abdominis plane block group | Experimental | Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125% Receives: Diagnostic Test: Tranversus Abdominis plane block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oxycodone used in the first 24 hours after surgery
Total cumulative oxycodone dose in mg used in the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (1)
Severity of postoperative pain via visual analogue pain scale (VAS)
VAS range from 0 for no pain to 10 for worst pain imaginable
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start31 Jul 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
- Investigators
- Tomasz Skladzien, MD PHD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606889
- Sponsor's protocol ID
- 1072.6120.107.2018
- Status last verified
- Jun 2022
- First submitted
- 11 Jul 2018
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
- ClinicalTrials.gov ID
- NCT03606889
- Acronym / sponsor ID
- 1072.6120.107.2018
- Conditions
- Prostatic Cancer, Pain, Postoperative, Pain, Anesthetics, Local
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum block group | Experimental | Diagnostic Test: Quadratus Lumborum block, Drug: BupivacaineQuadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125% |
| Transversus abdominis plane block group | Experimental | Diagnostic Test: Tranversus Abdominis plane block, Drug: BupivacaineTransversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus Lumborum blockAlso: QLB0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle | Diagnostic test | Quadratus Lumborum block group |
| Tranversus Abdominis plane blockAlso: TAP0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles. | Diagnostic test | Transversus abdominis plane block group |
| Bupivacaine0.2 ml/kg bupivicaine | Drug | Quadratus Lumborum block group, Transversus abdominis plane block group |
Primary outcome
Total oxycodone used in the first 24 hours after surgery
Time frame: 24 hours
Total cumulative oxycodone dose in mg used in the first 24 hours after surgery
1 secondary outcome
Severity of postoperative pain via visual analogue pain scale (VAS)
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: not enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Skladzien, MD PHD principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum block, Tranversus Abdominis plane block and Bupivacaine in people with Prostatic Cancer and Pain, Postoperative, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total oxycodone used in the first 24 hours after surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.