Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy
NCT ID: NCT04116008
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-11-10
2019-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective laparoscopic cholecystectomy
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Baskent University
OTHER
Responsible Party
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Omer Karaca
Director
Principal Investigators
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Halime Ozdemir, MD
Role: PRINCIPAL_INVESTIGATOR
Baskent University
Locations
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Baskent University,Konya
Konya, Selcuklu, Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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KA 19/152
Identifier Type: -
Identifier Source: org_study_id