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Analgesic Efficacy of Quadaratus Lumborum Block (QLB) for Laparoscopic Colectomy Surgery: A Prospective Case Control Trial to Evaluate Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT03017638
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

Pain after abdominal surgery can be extensive. Pain control is an important component of patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced Recovery after Surgery (ERAS) protocols.

Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy has been shown for abdominal surgeries, and also for different laparoscopic procedures, such as ovarian surgery.

The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy surgeries, using serial pain score assessments and overall opioid consumption; its effect on patient satisfaction; and its effect on the development of postoperative respiratory complications. This study is a prospective clinical trial assessing the effect of application of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to a historical retrospective cohort.


Condition or disease Intervention/treatment
Block Other: Questionaire

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Analgesic Efficacy of Quadaratus Lumborum Block (QLB) for Laparoscopic Colectomy Surgery: A Prospective Observational Case Control Trial to Evaluate Clinical Outcomes
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : January 14, 2018
Actual Study Completion Date : January 14, 2018

Group/Cohort Intervention/treatment
Patients receiving QLB and questionaires
Patients undergoing primary laparoscopic colectomy patients under general anesthesia with an additional Quadratus lumborum block (QLB ) will be asked to fill out a questionnaires detailing: numeric verbal analogue scores (VAS) and quality of recovery score(QoR) preoperatively, 24 hours and 48 hours and four weeks after surgery. Additional data will be collected: ASA physical status, demographics, intra- and post operative opiate(expressed as morphine equivalent in mg/kg) and non opiate consumption in order to assess the analgesic efficacy of QLB for primary laparoscopic colectomy. QLB will be performed as per standard routine regimens, in the operating room after induction of general anesthesia and prior to surgery.
Other: Questionaire
Patients undergoing primary laparoscopic colectomy patients under general anesthesia with an additional Quadratus lumborum block (QLB ) will be asked to fill out a questionnaires detailing: numeric verbal analogue scores (VAS) and quality of recovery score(QoR) preoperatively, 24 hours, 48 hour and four weeks after surgery. Additional data will be collected: ASA physical status, demographics, intra- and post operative opiate(expressed as morphine equivalent in mg/kg) and non opiate consumption in order to assess the analgesic efficacy of QLB for primary laparoscopic colectomy. QLB will be performed as per standard routine regimens, in the operating room after induction of general anesthesia and prior to surgery.

Historical control

The control subjects' data will be assessed reviewing patient records. Data will include:

  • Maximal PACU VAS pain score (per nursing charts)
  • Overall POD 24 hours and 48 hours and 4 weeks opioid consumption (overall morphine mg/kg equivalent dose)
  • POD 24 and 48 hours and 4 weeks Respiratory complications



Primary Outcome Measures :
  1. Verbal analogue scale (VAS) [ Time Frame: 24 Hours ]
    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) elicited during the patient's post operative recovery unit (PACU)

  2. Verbal analogue scale (VAS) [ Time Frame: 24 hours ]
    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) on postoperative day 1

  3. Verbal analogue scale (VAS) [ Time Frame: 48 hours ]
    patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) on postoperative day 2


Secondary Outcome Measures :
  1. Total opioid consumption in PACU [ Time Frame: 24 hours ]
    Total opioid consumption during PACU stay

  2. Total opioid consumption on postoperative day 1. [ Time Frame: 24 hours ]
    Total opioid consumption on postoperative day 1.

  3. Total opioid consumption postoperative day 2 [ Time Frame: 48 hours ]
  4. Total opioid consumption at four weeks postoperatively [ Time Frame: 4 weeks ]
  5. Length of hospital stay [ Time Frame: 1 week ]
    Total days of hospitalization

  6. Quality of recovery score (questionaire) four weeks postoperatively [ Time Frame: 4 weeks ]
  7. Quality of recovery score (questionaire) 1 day postoperatively [ Time Frame: 24 hours ]
  8. Quality of recovery score (questionaire) 48 postoperatively [ Time Frame: 48 hours ]
  9. Minimal saturation during PACU stay [ Time Frame: 24 hours ]
  10. Development of postoperative respiratory complications until patient discharge [ Time Frame: 1 week ]
    re-intubation, documented apneas, severe hypoxemia (measured saturations <94%; or arterial blood oxygen partial pressure in relation to inspired oxygen concentration [PaO2/FiO2] ration below 200)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include adults older than 18 years who are American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1-3. Inclusion criteria are patients undergoing primary laparoscop colectomy under general anesthesia with QLB.
Criteria

Inclusion Criteria:

All primary laparoscopic colectomy patients are eligible for inclusion in the study.

Exclusion Criteria:

  • Previous abdominal surgery
  • Allergy to local anesthetics or to systemic opioids
  • Contraindication to regional anesthesia technique, such as local infection or coagulopathy, or patients receiving anticoagulation therapy with smaller specifications than listed in professional guidelines.
  • Contraindication to the Quadratus lumborum block such as defects or interferences in the abdominal wall obstructing anatomical structure visibility.
  • Requirements of more than 30 mg morphine equivalent daily prior to surgery
  • ASA IV or greater
  • Psychiatric or cognitive disorders
  • Incarceration
  • Renal insufficiency with Cr > 2.0
  • Hepatic failure
  • Pregnancy
  • Age under 18 years

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): NCT03017638


Locations
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Israel
Rabin Medical Center
Petach Tikvah, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Shia Fein, MD Rabin Medical Center
Publications of Results:

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03017638    
Other Study ID Numbers: 0832-16
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: January 2017
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
Product Manufactured in and Exported from the U.S.: No