Pain Management in Laparoscopic Cholecystectomies

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

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.

Study Overview

• Status: Completed
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: ESPB; Procedure: PVB; Procedure: CONTROL

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

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Giresun, Merkez, Turkey, 28100
      • Giresun University Medical School Hospital.

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector Spinae Plane Block (ESPB); The spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block .	Procedure: ESPB; Erector spinae plane block
Active Comparator: Paravertebral Block (PVB); After sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed	Procedure: PVB; Paravertebral Block
Active Comparator: Control; No block has been done	Procedure: CONTROL; No block has been done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analgesic drug consumption other than tramadol	in mg	24 hours postoperatively
Heart Rate	beats /min	preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Mean arterial pressure (MAP)	mm-hg	preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Incidence of postoperative nausea & vomiting (PONV)	Number of patients developing PONV	24 hours postoperatively
Shoulder pain	Number of patients developing shoulder pain	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Giresun University
• Investigators: Study Director: elvan tekir yilmaz, Giresun University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Paravertebral Block
• Other Study ID Numbers: 2021/ 283

Drug and device information, study documents

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