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

Laparoscopic Cholecystectomy Clinical Trial

— M-TAPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017090
• Other study ID #: 05-2021/09
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: August 2021
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• M-TAPA block
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:
• Standard perioperative and postoperative multimodal analgesia
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.

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale scores	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).	24 hours
Secondary	Opioid consumption	If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.	24 hours
Secondary	Adverse events	Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.	24 hours
Secondary	Metoclopromide consumption	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.	24 hours
Secondary	Sedation score	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.	24 hours
Secondary	Quality of recovery levels between groups by using QoR-40 questionnaire	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.	Postoperative 24th hour