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Trial record 46 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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

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ClinicalTrials.gov Identifier: NCT03606889
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Tomasz Skladzien, Jagiellonian University

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.


Condition or disease Intervention/treatment Phase
Prostatic Cancer Pain, Postoperative Pain Anesthetics, Local Diagnostic Test: Quadratus Lumborum block Diagnostic Test: Tranversus Abdominis plane block Drug: Bupivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Quadratus Lumborum block group
Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Diagnostic Test: Quadratus Lumborum block
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Other Name: QLB

Drug: Bupivacaine
0.2 ml/kg bupivicaine

Experimental: Transversus abdominis plane block group
Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%
Diagnostic Test: Tranversus Abdominis plane block
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
Other Name: TAP

Drug: Bupivacaine
0.2 ml/kg bupivicaine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Severity of postoperative pain via visual analogue pain scale (VAS) [ Time Frame: 24 hours ]
    VAS range from 0 for no pain to 10 for worst pain imaginable



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate is only in males.
Accepts Healthy Volunteers:   No
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606889


Contacts
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Contact: Tomasz Skladzien, MD PHD 506602250 ext +48 t.skladzien@interia.pl

Locations
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Poland
University Hospital in Cracow Recruiting
Kraków, Poland, 31-501
Contact: Tomasz Skladzien, PhD    506602250 ext +48    t.skladzien@interia.pl   
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Tomasz Skladzien, MD PHD Jagiellonian University

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Responsible Party: Tomasz Skladzien, MD PHD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03606889     History of Changes
Other Study ID Numbers: 1072.6120.107.2018
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Prostatic Neoplasms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents