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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Laparoscopic Cholecystectomy; Regional Anesthesia
• Intervention / Treatment: Procedure: M-TAPA block; Drug: Tramadol; Procedure: EXORA block

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block	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; 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.
Active Comparator: Group E; Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block	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.; Procedure: EXORA block; Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
Active Comparator: Group P; Patient-controlled analgesia with tramadol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
additional analgesic use	additional analgesic use	Postoperative 24 hours
tramadol consumption		Postoperative 24 hours
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
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
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

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Korgün Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: 2023-3/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No