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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008002
• Other study ID #: 2023-3/1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: January 13, 2024

Study information

• Verified date: August 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, M.D
• Phone: +905057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 13, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• M-TAPA block
ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed
• EXORA block
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Drug:
• Tramadol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS	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"	Postoperative 24 hours
Secondary	tramadol consumption		Postoperative 24 hours
Secondary	side effect profile scores	1. 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.	Postoperative 24 hours
Secondary	additional analgesic use	additional analgesic use	Postoperative 24 hours
Secondary	pinprick test	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.	Postoperative 24 hours
Secondary	Ramsay Sedation Scale	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 )	Postoperative 24 hours