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Completed

NCT Number: NCT04761029

Rhomboid Intercostal and Subserratus Plane Block

Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

About this study

In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study

Exclusion criteria

  • bleeding disorders,
  • mental incapacity,
  • known allergy to the local anesthetics,
  • body mass index ≥35 kg/m2

Treatment and study plan

RIIS

Other

unilateral Rhomboid intercostal and subserratus block

Tramadol

Drug

intravenous patient-controlled analgesia (tramadol)

Primary outcomes

  1. tramadol consumption

    Time frame: Postoperative 24 hours

    tramadol consumption

Secondary outcomes

  1. Numeric Rating Scale rest

    Time frame: postoperative 24 hours

    Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Numeric Rating Scale during movement

    Time frame: Postoperative 24 hours

    Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  3. additional analgesic use

    Time frame: Postoperative 24 hours

    additional analgesic use

  4. side effect profile

    Time frame: Postoperative 24 hours

    side effect profile (Nausea and vomiting)

  5. sensorial dermatomal block-level

    Time frame: 30 minutes after the block administration and at the postoperative 2nd hour

    Dermatomal dispersion of sensorial block to the cold stimulus.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

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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