Rhomboid Intercostal and Subserratus Plane Block

Not Applicable

Completed

• Conditions: Nerve Block; Cholecystectomy; Postoperative Pain
• Interventions: Other: RIIS; Drug: Tramadol

• Registration Number: NCT04761029
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grup R	RIIS	Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia
grup R	Tramadol	Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia
Group P	Tramadol	intravenous patient-controlled analgesia

Primary Outcome Measures

Name	Time	Method
tramadol consumption	Postoperative 24 hours	tramadol consumption

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale rest	postoperative 24 hours	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).
Numeric Rating Scale during movement	Postoperative 24 hours	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).
additional analgesic use	Postoperative 24 hours	additional analgesic use
side effect profile	Postoperative 24 hours	side effect profile (Nausea and vomiting)
sensorial dermatomal block-level	30 minutes after the block administration and at the postoperative 2nd hour	Dermatomal dispersion of sensorial block to the cold stimulus.

Trial Locations

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey