Postoperative Pain
Conditions
Keywords
Laparoscopic Cholecystectomy, Erector Spinae Plane Block, Rhomboid Intercostal Subserratus Plane Block, Regional Anesthesia, Diaphragmatic Function, Postoperative Analgesia
Brief summary
This prospective randomized controlled trial aims to compare the analgesic efficacy and effects on diaphragmatic function of bilateral erector spinae plane (ESP) block and bilateral rhomboid intercostal-subserratus plane (RISS) block in patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, diaphragmatic excursion, pulmonary function, and recovery outcomes will be evaluated.
Detailed description
Postoperative pain after laparoscopic cholecystectomy may impair respiratory function and delay recovery. Fascial plane blocks have emerged as effective opioid-sparing analgesic techniques. The erector spinae plane (ESP) block and rhomboid intercostal-subserratus plane (RISS) block are ultrasound-guided regional anesthesia techniques that may provide effective postoperative analgesia while preserving respiratory mechanics. This prospective randomized controlled study will compare bilateral ESP block and bilateral RISS block in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The primary objective is to compare postoperative analgesic efficacy and diaphragmatic function. Secondary outcomes include postoperative opioid consumption, pain scores at rest and during movement, pulmonary function parameters, rescue analgesic requirements, and adverse events.
Interventions
PROCEDUREErector Spinae Plane Block
Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Bilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Sponsors
Ferit Yetik
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either bilateral erector spinae plane block (ESP) or bilateral rhomboid intercostal-subserratus plane block (RISS) before elective laparoscopic cholecystectomy. Outcomes will be compared between two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- * Age between 18 and 75 years * ASA physical status I-III * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Provision of written informed consent
Exclusion criteria
* Coagulation disorders or anticoagulant therapy * Known allergy to local anesthetics * Infection at the block application site * Pregnancy or lactation * Chronic opioid use * Cognitive impairment * Refusal to participate in the study * Technical inability to perform the block * Failed block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Tramadol Consumption | 24 hours after surgery | Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | 0-24 hours after surgery | Postoperative pain scores assessed using the Numeric Rating Scale (NRS). |
| Time to First Rescue Analgesia | 24 hours after surgery | Time from the end of surgery to first rescue analgesic requirement. |
| Intraoperative Remifentanil Consumption | During surgery | Total remifentanil consumption during surgery. |
| Opioid-Related Adverse Events | 24 hours after surgery | Incidence of nausea, vomiting, pruritus and other opioid-related adverse events. |
| Block-Related Complications | 24 hours after surgery | Complications associated with ESP block or RISS block. |
| Diaphragmatic Excursion | Preoperative and postoperative 24 hours | Right hemidiaphragm excursion measured by ultrasonography. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMürsel Ekinci, MD
CONTACTYusuf Alan, MD
PRINCIPAL_INVESTIGATORMürsel Ekinci, MD
Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine
Outcome results
None listed