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CompletedNCT03413280Updated Jan 23, 2019

Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

An interventional study of Ultrasound guided Rectus sheath block and Intercostal nerve block in Preemptive Peripheral Nerve Block, Pain, Postoperative and Acute Pain, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.

02

Conditions studied

  • Preemptive Peripheral Nerve Block
  • Pain, Postoperative
  • Acute Pain

Keywords

  • preemptive analgic effect
  • Rectus Sheath Block
  • laparoscopic cholecystectomy
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 who are pregnant or lactating
  6. Patients whose visceral pain is expected to be too severe
  7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    preoperative Rectus sheath block: group Pre

    ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

    Drug: Ultrasound guided Rectus sheath block · Drug: Intercostal nerve block

  • Active comparator
    postoperative Rectus sheath block: group Post

    ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision

    Drug: Ultrasound guided Rectus sheath block · Drug: Intercostal nerve block

Interventions

  • DrugUltrasound guided Rectus sheath block

    Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus

  • DrugIntercostal nerve block

    Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

05

What researchers measure

Primary outcomes

  1. Difference of analgesic consumption between both group

    The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation) to compare.

    Time frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

Secondary outcomes

  1. compare the Numeric rating scale (NRS)

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 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, 9, 18, 24 hours postoperatively).

    Time frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

06

Study locations

1 site
  • Asan Medical Center
    Seoul, Songpa-gu 05505, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03413280
Lead sponsor
Asan Medical Center
Responsible party
Jong Hyuk Lee (clinical assistant professor, Asan Medical Center) — Principal investigator
First posted
Jan 29, 2018
Start date
Mar 28, 2017
Primary completion
Aug 25, 2017
Completion
Jan 15, 2018
Last update
Jan 23, 2019

Study contacts

JongHyuk Lee, MD
principal investigator · Asan Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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