CClinicalTrials.gg
CompletedNCT05837702Updated May 3, 2023

Pain Management in Laparoscopic Cholecystectomies

An interventional study of ESPB and PVB in Nerve Block, sponsored by Giresun University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Giresun University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

02

Conditions studied

  • Nerve Block

Keywords

  • Erector Spinae Plane Block
  • Paravertebral Block
  • Laparoscopic Cholecystectomy
03

In context

Lead sponsor

Giresun University is the lead sponsor of 51 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Erector Spinae Plane Block (ESPB)

    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

  • Active comparator
    Paravertebral Block (PVB)

    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

  • Active comparator
    Control

    No block has been done

    Procedure: CONTROL

Interventions

  • ProcedureESPB

    Erector spinae plane block

  • ProcedurePVB

    Paravertebral Block

  • ProcedureCONTROL

    No block has been done

06

What researchers measure

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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Visual analog scale (VAS) at rest and when coughing

    11-point scale where 0=no pain and 10=worst pain

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

  2. Analgesic drug consumption other than tramadol

    in mg

    Time frame: 24 hours postoperatively

  3. Heart Rate

    beats /min

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

  4. Mean arterial pressure (MAP)

    mm-hg

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

  5. Incidence of postoperative nausea & vomiting (PONV)

    Number of patients developing PONV

    Time frame: 24 hours postoperatively

  6. Shoulder pain

    Number of patients developing shoulder pain

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Giresun University Medical School Hospital.
    Giresun, Merkez 28100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05837702
Lead sponsor
Giresun University
Responsible party
Elvan Yilmaz (Assistant Professor, Giresun University) — Principal investigator
First posted
May 1, 2023
Start date
Jan 10, 2022
Primary completion
Oct 10, 2022
Completion
Jan 10, 2023
Last update
May 3, 2023

Study contacts

elvan tekir yilmaz
study director · Giresun University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion