Rhomboid Intercostal and Subserratus Plane Block

Postoperative Pain Clinical Trial

Official title:

Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761029
• Other study ID #: 2011-KAEK-25
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.

Description:

In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study

Exclusion Criteria:

• bleeding disorders,

• mental incapacity,

• known allergy to the local anesthetics,

• body mass index =35 kg/m2

Related Conditions & MeSH terms

• Cholecystectomy
• Nerve Block
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• RIIS
unilateral Rhomboid intercostal and subserratus block

Drug:
• Tramadol
intravenous patient-controlled analgesia (tramadol)

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tramadol consumption	tramadol consumption	Postoperative 24 hours
Secondary	Numeric Rating Scale rest	Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).	postoperative 24 hours
Secondary	Numeric Rating Scale during movement	Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).	Postoperative 24 hours
Secondary	additional analgesic use	additional analgesic use	Postoperative 24 hours
Secondary	side effect profile	side effect profile (Nausea and vomiting)	Postoperative 24 hours
Secondary	sensorial dermatomal block-level	Dermatomal dispersion of sensorial block to the cold stimulus.	30 minutes after the block administration and at the postoperative 2nd hour