Pain Management in Laparoscopic Cholecystectomies

Giresun University

Status: Completed

Conditions: Nerve Block

Treatments: Procedure: CONTROL; Procedure: PVB; Procedure: ESPB

Study type: Interventional

Funder types: Other

Identifiers

NCT05837702

2021/ 283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Erector Spinae Plane Block (ESPB)

Experimental group

Description:

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 .

Treatment:

Procedure: ESPB

Paravertebral Block (PVB)

Active Comparator group

Description:

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

Treatment:

Procedure: PVB

Control

Active Comparator group

Description:

No block has been done

Treatment:

Procedure: CONTROL