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Clinical Trials/NCT04761029
NCT04761029CompletedNot Applicable

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

Bursa Yüksek İhtisas Education and Research Hospital1 site in 1 country50 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
tramadol consumption

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

grup R

Active Comparator

Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia

Intervention: RIIS (Other)

grup R

Active Comparator

Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia

Intervention: Tramadol (Drug)

Group P

Placebo Comparator

intravenous patient-controlled analgesia

Intervention: Tramadol (Drug)

Outcomes

Primary Outcomes

tramadol consumption

Time Frame: Postoperative 24 hours

tramadol consumption

Secondary Outcomes

  • Numeric Rating Scale rest(postoperative 24 hours)
  • Numeric Rating Scale during movement(Postoperative 24 hours)
  • additional analgesic use(Postoperative 24 hours)
  • side effect profile(Postoperative 24 hours)
  • sensorial dermatomal block-level(30 minutes after the block administration and at the postoperative 2nd hour)

Investigators

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Korgün Ökmen

Principal Investigator ,Assoc. PhD. M.D.

Bursa Yüksek İhtisas Education and Research Hospital

Study Sites (1)

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