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

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

Study Overview

• Status: Completed
• Conditions: Visceral Pain, Postoperative
• Intervention / Treatment: Drug: Ultrasound guided Rectus sheath block; Drug: Ultrasound erector spinae plane block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; visceral pain; erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Nociceptive Pain; Pain, Postoperative; Visceral Pain
• Other Study ID Numbers: 2018-1320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No