Ultrasound Guided Bilateral Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Maltepe University

Status: Completed

Conditions: Postoperative Pain

Treatments: Other: Standard Pain Followup and Monitorization; Procedure: Ultrasound guided erector spinae plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT03391167

MaltepeU

Details and patient eligibility

About

This study will define the postoperative analgesic effect of ESP block via amount of patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely and rescue analgesics) and compare the control group in patients having laparoscopic Cholecystectomy .

Full description

Laparoscopic interventions are considered as minimally invasive procedures. They have both cosmetic and open surgery advantages in terms of surgical stress. Laparoscopic cholecystectomy is the most commonly performed laparoscopic upper abdominal procedure. After this procedure, patients often complain of excessive pain. Non-steroidal anti-inflammatory agents and opioids are used for postoperative analgesia. In addition, in the past decade, in the guideline of ultrasonography, peripheral block types with analgesic activity have been described in laparoscopic cholecystectomies as well as in many operations on the development of regional anesthesia and analgesia techniques. It was reported that transverse abdominis plane (TAP) block provided effective analgesia in these cases in the first ultrasonography guideline of petit triangle region in 2010. Later studies on TAP block activity, drug doses and concentrations in laparoscopic cholecystectomies have been conducted. There are also publications indicating that TAP block has been applied to the subcostal region for more effective analgesia. The ESP block is a new block for the treatment of thoracic neuropathic pain. In the following process; ESP block thoracic and breast surgery, bariatric surgery, and upper abdominal surgeons have also been reported to provide effective postoperative analgesia .

The standard practice for post-operative pain management for laparoscopic cholecystectomy in Maltepe University Hospital consists of routine intravenous analgesic and rescue analgesics and in combination with patient-controlled analgesia (PCA).

Given the importance of providing adequate analgesia in upper abdomen surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, the investigators are proposing a prospective observational study to examine the analgesic efficacy of the ESP block in laparoscopic cholecystectomy as a potential analgesic technique. The investigators are hoping the results of this study will provide framework for future larger comparative studies.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion criteria

• Patient refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system
• Patient with psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control

Sham Comparator group

Description:

Peroperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

Treatment:

Other: Standard Pain Followup and Monitorization

ESP Block

Experimental group

Description:

In addition to routine analgesic protocol; before anaesthesia induction; bilateral ultrasound guided erector spinae plane block (ESP) (intervention) will be performed via USG guidance at Th9 level.Standard Pain Followup and Monitorization will be performed.

Treatment:

Other: Standard Pain Followup and Monitorization

Procedure: Ultrasound guided erector spinae plane block