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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767816
Enrollment
60
Registered
2018-12-07
Start date
2018-12-17
Completion date
2019-06-30
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Pain, Postoperative

Keywords

laparoscopic cholecystectomy, erector spinae plane block, visceral pain

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

Interventions

Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference of analgesic consumption between both groupat 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operationThe 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

MeasureTime frameDescription
compare the Numeric rating scale (NRS)at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation10 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026