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

Postoperative Pain Clinical Trial

Official title:

Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508531
• Other study ID #: ESPvsOSTAP
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: May 21, 2018

Study information

• Verified date: May 2018
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• ESP Block
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 40 mL of bupivacaine/lidocaine mixture will be injected.
• OSTAP block
The bilateral OSTAP will be performed at the end of the surgery. A total of 40 ml local anesthetic mixture (Bupivacaine and lidocaine) will be injected bilaterally with interfascial plane between the external oblique and transversus abdominis muscles

Other:
• Standard Pain Followup and Monitorization
Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 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 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 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.

Locations

Country	Name	City	State
Turkey	Maltepe University faculty of medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Aksu C, Gürkan Y. Ultrasound-guided bilateral erector spinae plane block could provide effective postoperative analgesia in laparoscopic cholecystectomy in paediatric patients. Anaesth Crit Care Pain Med. 2018 Apr 6. pii: S2352-5568(18)30084-5. doi: 10.1016/j.accpm.2018.03.008. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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	analgesic consumption	Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using	24 hours