Pain Management in Laparoscopic Cholecystectomies

Not Applicable

Completed

• Conditions: Nerve Block

• Registration Number: NCT05837702
• Lead Sponsor: Giresun University

Brief Summary

Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed Description

The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-10-10
• Study Completion: 2023-01-10
• Status Verified: 2023-04
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-30
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

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

Inclusion Criteria

• aged >18 years
• patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria

• Did not provide informed consent,
• Had any psychiatric or mental problem that prevented understanding of the informed consent form
• They were planned to undergo emergency cholecystectomy,
• Had any allergy or hypersensitivity to local anaesthetic,
• Had an infection in the needle entry area
• History of coagulopathy or the use of anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total tramadol consumption	24 hours postoperatively	Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.

Secondary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) at rest and when coughing	at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively	11-point scale where 0=no pain and 10=worst pain
Analgesic drug consumption other than tramadol	24 hours postoperatively	in mg
Heart Rate	preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)	beats /min
Mean arterial pressure (MAP)	preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)	mm-hg
Incidence of postoperative nausea & vomiting (PONV)	24 hours postoperatively	Number of patients developing PONV
Shoulder pain	24 hours postoperatively	Number of patients developing shoulder pain

Trial Locations

Locations (1)

Giresun University Medical School Hospital.; 🇹🇷 Giresun, Merkez, Turkey