Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: ESP Block; Procedure: OSTAP block; Other: Standard Pain Followup and Monitorization

• Registration Number: NCT03508531
• Lead Sponsor: Maltepe University

Brief Summary

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Status Verified: 2018-05
• Primary Completion: 2018-05-21
• Study Completion: 2018-05-21
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESP Block	ESP Block	Ultrasound-guided bilateral Erector spinae plane block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative 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.
OSTAP Block	OSTAP block	Ultrasound-guided bilateral OSTAP block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative 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	Ultrasound-guided bilateral Erector spinae plane block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative 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.
Control	Standard Pain Followup and Monitorization	Perioperative 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. No block will be performed in this group.
OSTAP Block	Standard Pain Followup and Monitorization	Ultrasound-guided bilateral OSTAP block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative 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.

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