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Effectiveness of a Transmuscular Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023462
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Brief Summary:
One of the most common complications after hernia repair is postoperative and chronic pain. TAP (transverse abdominis plain) block is a recommended multimodal method of reducing postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this study is to determine whether the use of a perioperative echo guided unilateral TAP block has a superior effect on postoperative pain after laparoscopic inguinal repair compared to the transmuscular Quadratus Lumborum Block with a long acting local anesthetic.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Pain, Postoperative Drug: Oksykodonhydroklorid Drug: Ondansetron and Droperidol Drug: Ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Group QLB: transmuscular Quadratus Lumborum Block using ropivacaine 7,5 mg/ml, 20ml. Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml.
  • Group TAP: Transversus abdominis plane block using ropivacaine 7,5 mg/ml, 20 ml Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Computer generated randomization with allocation in opaque envelopes. Randomization performed by other study personell than care provider.
Primary Purpose: Treatment
Official Title: Effectiveness of a Transmuscular Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
Drug Information available for: Ondansetron

Arm Intervention/treatment
Active Comparator: Transmuscular Quadratus lumborum Block
A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Other Name: oxycodone

Drug: Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Name: Ondansetron and Dridol

Drug: Ropivacaine
Local anesthetic for the block

Active Comparator: TAP Block
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Other Name: oxycodone

Drug: Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Name: Ondansetron and Dridol

Drug: Ropivacaine
Local anesthetic for the block




Primary Outcome Measures :
  1. Opioid consumption measured as orale morphine equivalents. [ Time Frame: 0 - 4 hours ]
    Differences in opioid consumption after four hours.


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 0 - 7 days postoperative. ]
    Nausea is measured by a NRS score 0-3 at the timepoints 4 hours, 24 hours, 48 hours and 7 days.

  2. Sedation scores [ Time Frame: 0 - 7 days postoperative. ]
    Sedation is measured by a NRS score 0-3 at the timepoints 4 hours, 24 hours, 48 hours and 7 days.

  3. Opioid consumption measured in orale morphine equivalents. [ Time Frame: 4 hours- 7 days postopertive. ]
    Opioid consumption measured at 24 hours, 48 hours and seven days.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria;

  • Age > 18 years
  • BMI (body mass index) 20-35
  • ASA (American Association of Anesthesiologists Classification system for physical status) I-III.
  • Scheduled for elective laparoscopic inguinal hernia operation

Exclusion criteria:

  • Allergy to latex, local anesthesia or opioids
  • Chronic pain with daily opiate use
  • Patients with severe renal and/or hepatic disease
  • Local infection at the site of injection
  • Systemic infection
  • AV block 2-3
  • Inability to understand written or spoken Norwegian
  • Inability to cooperate
  • Dementia
  • Known abuse of alcohol or medication
  • Coagulation disorder
  • Pregnancy Previously operated with same side operation.

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): NCT03023462


Contacts
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Contact: Jan Sverre Vamnes, MD, Ph.D. +47 913 050 16 jan.sverre.vamnes@so-hf.no
Contact: Marie Sørenstua, MD +47 9097 68 830 marie.sorenstua@so-hf.no

Locations
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Norway
Ostfold Hospital Trust, Moss Recruiting
Moss, Ostfold, Norway, 1500
Contact: Jan Sverre Vamnes, MD, Ph.D.    +47 91608896    janvam@so-hf.no   
Contact: Knut Inge Solbakk, md    +47 90933106    knisol@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
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Study Chair: Jan Sverre Vamnes, MD, Ph.D. Senior consultant
Publications:

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03023462    
Other Study ID Numbers: AB3384
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No sharing plan so far

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ostfold Hospital Trust:
Transmuscular Quadratus Lumborum block
Transversus Abdominis block
Truncal block
Additional relevant MeSH terms:
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Hernia
Pain, Postoperative
Hernia, Inguinal
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Hernia, Abdominal
Droperidol
Oxycodone
Ondansetron
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents