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The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03437187
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Sverre Vamnes, Ostfold Hospital Trust

Brief Summary:
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.

Condition or disease Intervention/treatment Phase
Cholecystectomy Quadratus Lumborum Block Procedure: Cholecystectomy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
Primary Purpose: Treatment
Official Title: The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Cholecystectomy without nerve blocks
Cholecystectomy, enteral and parenteral analgesics
Procedure: Cholecystectomy
Laparoscopic technique
Other Names:
  • Quadratus lumborum block with Naropin
  • Quadratus lumborum block with Nacl
  • Traditional analgesics

Placebo Comparator: Cholecystectomy with placebo nerve block
Cholecystectomy, NaCl as a placebo Quadratus lumborum block
Procedure: Cholecystectomy
Laparoscopic technique
Other Names:
  • Quadratus lumborum block with Naropin
  • Quadratus lumborum block with Nacl
  • Traditional analgesics

Active Comparator: Cholecystectomy with naropin nerve block
Cholecystectomy, Quadratus lumborum block with naropin
Procedure: Cholecystectomy
Laparoscopic technique
Other Names:
  • Quadratus lumborum block with Naropin
  • Quadratus lumborum block with Nacl
  • Traditional analgesics




Primary Outcome Measures :
  1. Use of analgesics -"change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    Amount of analgesics used postoperative


Secondary Outcome Measures :
  1. Pain at the incision site - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    VAS (visual analog score; 0 - 100) 0 = no pain, 100 = severe pain

  2. Deep pain and pain on coughing - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    VAS (visual analog score; 0 - 100) 0 = no pain, 100 = severe pain

  3. Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    Amount of different medicaments in mg

  4. Postoperative nausea and vomiting - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    0-3 score where 0=none, 1=little nausea, 2=can not eat, 3=vomiting

  5. Antiemetic administered - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    Amount of different medicaments in mg

  6. Sedation scores - "change" is being assessed [ Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs) (48-168hrs) ]
    Sleepy or active. Score: Awake = 0, tired= 1, falls asleep = 2, Asleep all the time = 3



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 Years
  • BMI 20-35
  • ASA physical status I-II

Exclusion Criteria:

  • Allergy to local anaesthetics
  • Chronic pain requiring opioid analgesics
  • Patients with atrioventricular block II
  • Patients treated with class III antiarrhythmics
  • Patients with severe renal and/or hepatic disease
  • A coagulation disorder
  • An infection at the LA injection place

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): NCT03437187


Contacts
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Contact: Jan Sverre Vamnes, MD, Ph.D. +47 91305016 jansverre@vamnes.no

Locations
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Norway
Ostfold Hospital Trust, Moss Recruiting
Grålum, Ostfold, Norway, 1714
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

Publications of Results:

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Responsible Party: Jan Sverre Vamnes, Senior consultant, MD, Ph.D., Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03437187     History of Changes
Other Study ID Numbers: 1812
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Analgesics
Ropivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants