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OpenTrials
Completed

NCT Number: NCT05837702

Pain Management in Laparoscopic Cholecystectomies

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.

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Key information

Conditions

Nerve Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University Medical School Hospital.

Giresun, Merkez, 28100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ESPB

Procedure

Erector spinae plane block

PVB

Procedure

Paravertebral Block

Control

Procedure

No block has been done

Primary outcomes

  1. Total tramadol consumption

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

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

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

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

  2. Analgesic drug consumption other than tramadol

    Time frame: 24 hours postoperatively

    in mg

  3. Heart Rate

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

    beats /min

  4. Mean arterial pressure (MAP)

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

    mm-hg

  5. Incidence of postoperative nausea & vomiting (PONV)

    Time frame: 24 hours postoperatively

    Number of patients developing PONV

  6. Shoulder pain

    Time frame: 24 hours postoperatively

    Number of patients developing shoulder pain

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 1, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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