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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Pain, Postoperative; Prostatic Cancer; Anesthetics, Local
• Intervention / Treatment: Diagnostic test: Quadratus Lumborum block; Drug: Bupivacaine; Diagnostic test: Tranversus Abdominis plane block

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 31-501
    • University Hospital in Cracow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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%	Drug: Bupivacaine; 0.2 ml/kg bupivicaine; Diagnostic test: Tranversus Abdominis plane block; 0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.; Other Names: TAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative pain via visual analogue pain scale (VAS)	VAS range from 0 for no pain to 10 for worst pain imaginable	24 hours

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Principal Investigator: Tomasz Skladzien, MD PhD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Pain, Postoperative; Prostatic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1072.6120.107.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No