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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767816
Other study ID # 2018-1320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date June 30, 2019

Study information

Verified date July 2019
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
Ultrasound guided Rectus sheath block
Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus
Ultrasound erector spinae plane block
Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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, 12, 18, 24 hours after operation) to compare.
at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
Secondary compare the Numeric rating scale (NRS) 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).
at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation