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

Overview

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.

Full Title of Study: “Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 26, 2019

Interventions

  • Other: Standard Pain Followup and Monitorization
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Erector Spinae Block
    • 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.
  • Active Comparator: Subcostal Abdominis Plane Block
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Pain Score
    • Time Frame: 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 Measures

  • analgesic consumption
    • Time Frame: at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours
    • Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
  • block related complication
    • Time Frame: in this block performing time, till patients anesthetized right after block procedure, at PACU, 2nd, 4th, 6th, 12th and 24th hours
    • local anesthetic systemic toxicity during and after block procedure , pneumothorax and vascular puncture during block procedure
  • opioid complication
    • Time Frame: at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours
    • sedation, itching, nausea and vomiting

Participating in This Clinical Trial

Inclusion Criteria

  • ASA I-II-III – Undergoing elective laparoscopic cholecystectomy Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baskent University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Omer Karaca, Director – Baskent University
  • Overall Official(s)
    • Halime Ozdemir, MD, Principal Investigator, Baskent University

References

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.