Ultrasound Guided Bilateral Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Ultrasound guided erector spinae plane block; Other: Standard Pain Followup and Monitorization

• Registration Number: NCT03391167
• Lead Sponsor: Maltepe University

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2018-02-20
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	Ultrasound guided erector spinae plane block	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.
Control	Standard Pain Followup and Monitorization	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.
ESP Block	Standard Pain Followup and Monitorization	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.

Primary Outcome Measures

Name	Time	Method
Pain	24 hours	Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Secondary Outcome Measures

Name	Time	Method
analgesic consumption	24 hours	Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using

Trial Locations

Locations (1)

Maltepe University faculty of medicine; 🇹🇷 Istanbul, Turkey