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

Not Applicable

Completed

• Conditions: Postoperative Pain; Regional Anesthesia; Laparoscopic Cholecystectomy
• Interventions: Procedure: M-TAPA block; Procedure: EXORA block; Drug: Tramadol

• Registration Number: NCT06008002
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-23
• Study Start: 2023-08-25
• Primary Completion: 2023-12-25
• Study Completion: 2024-01-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M	M-TAPA block	ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
Group E	EXORA block	Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block
Group M	Tramadol	ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
Group E	Tramadol	Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block
Group P	Tramadol	Patient-controlled analgesia with tramadol

Primary Outcome Measures

Name	Time	Method
NRS	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 Outcome Measures

Name	Time	Method
side effect profile scores	Postoperative 24 hours	1. Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present,; 2. Mild nausea is present.; 3. Severe nausea is present.; 4. Vomiting is present) In case of a NVS score of \>3, an anti-emetic drug was administered.
tramadol consumption	Postoperative 24 hours
Ramsay Sedation Scale	Postoperative 24 hours	Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated,awake; 3. Sedated , response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and; 6. Sleepy, no response to auditory stimulus or glabella tap )
additional analgesic use	Postoperative 24 hours	additional analgesic use
pinprick test	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.

Trial Locations

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey