Comparation of Bilateral and Unilateral Erector Spinae Plane Block

NCT05152602 | Completed

• 1 other identifier: E2-21-228
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Although laparoscopic cholecystectomy is a minimally invasive surgery with many advantages, it is one of the operations with high postoperative pain scores. Opioids are frequently used to prevent postoperative pain. Due to the side effects of opioids, the amount of use is tried to be reduced. Regional anesthesia techniques can be used to minimize opioid consumption. Erector spina plane block was first described in 2016 by Forero et al. in the treatment of thoracic neuropathic pain. Since then, ESP block has been used as an anesthetic and analgesic technique. It is applied by injecting local anesthetic into the fascial plane located between the erector spina muscle and the transverse process of the vertebra. Several high-level studies have shown that the ESP block can be used to reduce postoperative pain after gastrointestinal surgery. Several studies have evaluated the effect of ESP block for pain relief after laparoscopic cholecystectomy. ESP block has been applied unilaterally or bilaterally in various studies. However, in the current studies in the literature, the advantages or disadvantages of the bilateral application of the ESP block compared to the unilateral application have not been evaluated. In this study, the investigators aimed to evaluate postoperative pain by applying ESP block to patients who underwent laparoscopic cholecystectomy and to evaluate the advantages of unilateral or bilateral application of ESP block over each other.

Conditions

Postoperative Pain, Acute; Regional Anesthesia; Multimodal Analgesia

Keywords

ESP block

Outcome Measures

Primary Outcomes (2)

• Visual analog scale

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

  0-24 hour

• Opioid consumption

  Total usage of opioid's dosage when the patients VAS scores over than the four

  24 hour

Study Arms (3)

Unilateral ESP block group

The group who underwent laparoscopic cholecystectomy and underwent unilateral ESP block for postoperative analgesia.

Procedure: Unilateral Erector spinae plane block

Bilateral ESP block group

The group who underwent laparoscopic cholecystectomy and underwent bilateral ESP block for postoperative analgesia.

Procedure: Bilateral Erector spinae plane block

Control group

The group that underwent laparoscopic cholecystectomy and underwent 1mg/kg tramadol and 50mg dexketoprofen for postoperative pain.

Interventions

Bilateral Erector spinae plane block PROCEDURE

Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle. It is supposed to work at the origin of spinal nerves based on cadaveric and contrast study. It has emerged as an effective and safe analgesic regional technique. It will be done at T7-8 level

Bilateral ESP block group

Unilateral Erector spinae plane block PROCEDURE

Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle. It is supposed to work at the origin of spinal nerves based on cadaveric and contrast study. It has emerged as an effective and safe analgesic regional technique. It will be done at T7-8 level

Unilateral ESP block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had laparoscopic cholecystectomy between December 2021 and January 2022.

You may qualify if:

• Patients who underwent laparoscopic cholecystectomy surgery between December 2021 and January 2022 will participate in the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• Huang J, Liu JC. Ultrasound-guided erector spinae plane block for postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Apr 14;20(1):83. doi: 10.1186/s12871-020-00999-8.

  PMID: 32290814 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 RESULT

• Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111.

  PMID: 34177291 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ayça T. Dumanlı Özcan, Assoc. Prof.

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2022
• Primary Completion: February 28, 2022
• Study Completion: March 10, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

TU (1)