Comparation of Bilateral and Unilateral Erector Spinae Plane Block

NCT ID: NCT05152602

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-03-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Unilateral ESP block group

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

Unilateral Erector spinae plane block

Intervention Type: 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

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

Bilateral Erector spinae plane block

Intervention Type: 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

Control group

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

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayça T. Dumanlı Özcan, Assoc. Prof.

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32290814 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27501016 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34177291 (View on PubMed)

Other Identifiers

E2-21-228

Identifier Type: -

Identifier Source: org_study_id