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The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03767816
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jong Hyuk Lee, Asan Medical Center

Brief Summary:

The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.

After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.

NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected


Condition or disease Intervention/treatment Phase
Visceral Pain, Postoperative Drug: Ultrasound guided Rectus sheath block Drug: Ultrasound erector spinae plane block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Group R : Rectus sheath block group
ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision
Drug: Ultrasound guided Rectus sheath block
Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Active Comparator: Group RE: Rectus sheath block and erector spinae plane block
ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml
Drug: Ultrasound guided Rectus sheath block
Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Drug: Ultrasound erector spinae plane block
Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level




Primary Outcome Measures :
  1. Difference of analgesic consumption between both group [ Time Frame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation ]

    The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5,

    1, 2, 6, 12, 18, 24 hours after operation) to compare.



Secondary Outcome Measures :
  1. compare the Numeric rating scale (NRS) [ Time Frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation ]

    10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.

    After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).




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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adults between the ages of 20 and 80
  2. scheduled laparoscopic cholecystectomy patient
  3. American society of anesthesiologists score 1 or 2
  4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

  1. Patient with side effects on local anesthetics or steroids
  2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  3. Patients with uncontrolled medical or psychiatric problem
  4. Patient does not agree to participate in the study
  5. Patients with deformity at vertebra or chest wall.
  6. Patients who are pregnant or lactating
  7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
  8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

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): NCT03767816


Contacts
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Contact: JongHyuk Lee, MD 82230101416 leejhpain@amc.seoul.kr
Contact: HyeMee Kwon, MD 821073108511 greentea8511@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 05505
Contact: JongHyuk Lee, MD    82230101416    leejhpain@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: JongHyuk Lee, MD Asan Medical Center

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Responsible Party: Jong Hyuk Lee, clinical assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03767816     History of Changes
Other Study ID Numbers: 2018-1320
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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

Keywords provided by Jong Hyuk Lee, Asan Medical Center:
laparoscopic cholecystectomy
erector spinae plane block
visceral pain

Additional relevant MeSH terms:
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Pain, Postoperative
Visceral Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nociceptive Pain
Ropivacaine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents