Pain Management in Laparoscopic Cholecystectomies

Nerve Block Clinical Trial

Official title:

Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837702
• Other study ID #: 2021/ 283
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: April 2023
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 10, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block

Intervention

Procedure:
• ESPB
Erector spinae plane block
• PVB
Paravertebral Block
• CONTROL
No block has been done

Locations

Country	Name	City	State
Turkey	Giresun University Medical School Hospital.	Giresun	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

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