NCT05837702

Brief Summary

Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

April 6, 2023

Last Update Submit

April 30, 2023

Conditions

Nerve Block

Keywords

Erector Spinae Plane BlockParavertebral BlockLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Total tramadol consumption

    Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.

    24 hours postoperatively

Secondary Outcomes (6)

  • Visual analog scale (VAS) at rest and when coughing

    at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively

  • Analgesic drug consumption other than tramadol

    24 hours postoperatively

  • Heart Rate

    preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)

  • Mean arterial pressure (MAP)

    preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)

  • Incidence of postoperative nausea & vomiting (PONV)

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (3)

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

The spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block .

Procedure: ESPB

Paravertebral Block (PVB)

ACTIVE COMPARATOR

After sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed

Procedure: PVB

Control

ACTIVE COMPARATOR

No block has been done

Procedure: CONTROL

Interventions

ESPBPROCEDURE

Erector spinae plane block

Erector Spinae Plane Block (ESPB)
PVBPROCEDURE

Paravertebral Block

Paravertebral Block (PVB)
CONTROLPROCEDURE

No block has been done

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged \>18 years
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

You may not qualify if:

  • Did not provide informed consent,
  • Had any psychiatric or mental problem that prevented understanding of the informed consent form
  • They were planned to undergo emergency cholecystectomy,
  • Had any allergy or hypersensitivity to local anaesthetic,
  • Had an infection in the needle entry area
  • History of coagulopathy or the use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University Medical School Hospital.

Giresun, Merkez, 28100, Turkey (Türkiye)

Location

Study Officials

  • elvan tekir yilmaz

    Giresun University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 1, 2023

Study Start

January 10, 2022

Primary Completion

October 10, 2022

Study Completion

January 10, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

TU(1)