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NCT Number: NCT05017090

Analgesic Effect of Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach

This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.

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Key information

Conditions

Laparoscopic Cholecystectomy Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

Exclusion criteria

  • presence of coagulation disorder
  • refuse to participate
  • infection at the injection site of the block
  • known allergy to local anesthetics
  • advanced hepatic or renal failure
  • can not communicate in Turkish
  • history of abdominal surgery or trauma
  • conversion of laparoscopic to open surgery
  • consumption of any pain killers within the 24 h before the operation
  • chronic opioid consumption
  • pregnancy
  • alcohol or drug abuse
  • body mass index (BMI) ≥ 35 kg m-2.

Treatment and study plan

m-TAPA block

Procedure

After tracheal intubation, a high-frequency linear probe will placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.

Other names: Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization

Standard perioperative and postoperative multimodal analgesia

Other

The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.

Other names: Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization

Primary outcomes

  1. Numerical Rating Scale scores

    Time frame: 24 hours

    The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).

Secondary outcomes

  1. Opioid consumption

    Time frame: 24 hours

    If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

  2. Adverse events

    Time frame: 24 hours

    Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.

  3. Metoclopromide consumption

    Time frame: 24 hours

    The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.

  4. Sedation score

    Time frame: 24 hours

    Sedation level of the patients will be assessed on a 4-point scale (0=alert, 1=sleepy, easy to arouse verbally, 2= drowsy, 3=does not open eyes to verbal commands) at postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour.

  5. Quality of recovery levels between groups by using QoR-40 questionnaire

    Time frame: Postoperative 24th hour

    QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.Global QoR-40 scores range from 40 to 200 representing, respectively, very poor to outstanding quality of recovery. QoR-40 score will be recorded on the morning of operation and at the postoperative 24th hour.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach in Patients Undergoing Laparoscopic Cholecystectomy

Acronym: M-TAPA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Dec 13, 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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