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

NCT04116008 | Completed

• 1 other identifier: KA 19/152
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 Subcostal transverse abdominis plane block (STAP) 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 STAP in laparoscopic cholecystectomy.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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").

  24 hours

Secondary Outcomes (3)

• analgesic consumption

  at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours

• block related complication

  in this block performing time, till patients anesthetized right after block procedure, at PACU, 2nd, 4th, 6th, 12th and 24th hours

• opioid complication

  at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours

Study Arms (2)

Erector Spinae Block

ACTIVE COMPARATOR

Ultrasound-guided bilateral Erector spinae plane block performed at end of the surgery with 40 ml of a bupivacaine/prilocaine 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.

Other: Standard Pain Followup and Monitorization

Subcostal Abdominis Plane Block

ACTIVE COMPARATOR

Ultrasound-guided bilateral STAP block performed at end of the surgery with 40 ml of a bupivacaine/prilocaine 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.

Other: Standard Pain Followup and Monitorization

Interventions

Standard Pain Followup and Monitorization OTHER

Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.

Erector Spinae Block; Subcostal Abdominis Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II-III
• Undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• obesity
• ASA IV
• infection of the skin at the site of needle puncture area
• patients with known allergies to any of the study drugs
• coagulopathy
• recent use of analgesic drugs
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system
• Patient with psychiatric disorders

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University,Konya

Konya, Selcuklu, 42080, Turkey (Türkiye)

Location

Related Publications (2)

• Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.

  PMID: 25948166 BACKGROUND

• Aksu C, Gurkan Y. Ultrasound-guided bilateral erector spinae plane block could provide effective postoperative analgesia in laparoscopic cholecystectomy in paediatric patients. Anaesth Crit Care Pain Med. 2019 Feb;38(1):87-88. doi: 10.1016/j.accpm.2018.03.008. Epub 2018 Apr 6. No abstract available.

  PMID: 29630940 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Halime Ozdemir, MD

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Controlled randomized study

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 10, 2019
• Primary Completion: November 26, 2019
• Study Completion: December 24, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

TU (1)