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Completed

NCT Number: NCT04116008

Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic Subcostal transverse abdominis plane block (STAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and STAP in laparoscopic cholecystectomy.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University,Konya

Konya, Selcuklu, 42080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA I-II-III
  • Undergoing elective laparoscopic cholecystectomy

Exclusion criteria

  • obesity
  • ASA IV
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

Treatment and study plan

Standard Pain Followup and Monitorization

Other

Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.

Primary outcomes

  1. Pain Score

    Time frame: 24 hours

    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Secondary outcomes

  1. analgesic consumption

    Time frame: at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours

    Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using

  2. block related complication

    Time frame: in this block performing time, till patients anesthetized right after block procedure, at PACU, 2nd, 4th, 6th, 12th and 24th hours

    local anesthetic systemic toxicity during and after block procedure , pneumothorax and vascular puncture during block procedure

  3. opioid complication

    Time frame: at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours

    sedation, itching, nausea and vomiting

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2019
Registry last updated
Dec 26, 2019

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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