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Completed

NCT Number: NCT06008002

Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

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Key information

Conditions

Postoperative Pain Laparoscopic Cholecystectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Regional Anesthesia Signs and Symptoms

Age range

18 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 our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • laparoscopic cholecystectomy surgery
  • Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

Exclusion criteria

  • Uncontrolled Arterial Hypertension
  • Uncontrolled Diabetes Mellitus,
  • Mental retardation ,
  • Antidepressant use
  • Metabolic disorders,
  • Bleeding diathesis
  • Patients with a body mass index above 30.

Treatment and study plan

m-TAPA block

Procedure

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed

EXORA block

Procedure

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Tramadol

Drug

400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Primary outcomes

  1. NRS

    Time frame: Postoperative 24 hours

    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary outcomes

  1. tramadol consumption

    Time frame: Postoperative 24 hours

  2. side effect profile scores

    Time frame: Postoperative 24 hours

    • Nausea and vomiting scale (nausea-vomiting scale (NVS):
    • No nausea is present,
    • Mild nausea is present.
    • Severe nausea is present.
    • Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.

  3. additional analgesic use

    Time frame: Postoperative 24 hours

    additional analgesic use

  4. pinprick test

    Time frame: Postoperative 24 hours

    The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.

    With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.

  5. Ramsay Sedation Scale

    Time frame: Postoperative 24 hours

    Ramsay Sedation Scale (RSS) :

    • Anxiety, agitation are present;
    • Cooperated,awake;
    • Sedated , response to commands;
    • Sleepy, immediately awoken by auditory stimulus or glabella tap;
    • Sleepy, deep response to auditory stimulus or glabella tap and
    • Sleepy, no response to auditory stimulus or glabella tap )

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 23, 2023
Registry last updated
Aug 12, 2024

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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