Comparation of Bilateral and Unilateral Erector Spinae Plane Block

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05152602
Collaborator
(none)
45
3

Study Details

Study Description

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 our study, we 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bilateral Erector spinae plane block
  • Procedure: Unilateral Erector spinae plane block

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Bilateral and Unilateral Erector Spinae Plane Block on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jan 30, 2022
Anticipated Study Completion Date :
Mar 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Unilateral ESP block group

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

Procedure: Unilateral Erector spinae plane block
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

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

Procedure: Bilateral Erector spinae plane block
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

Control group

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

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale [0-24 hour]

    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.

  2. Opioid consumption [24 hour]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients who underwent laparoscopic cholecystectomy surgery between December 2021 and January 2022 will participate in the study.
Exclusion Criteria:
  • There is no exclusion criteria for the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Study Chair: Ayça T. Dumanlı Özcan, Assoc. Prof., Ankara City Hospital Bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05152602
Other Study ID Numbers:
  • E2-21-228
First Posted:
Dec 10, 2021
Last Update Posted:
Dec 10, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2021