Laparoscopic Cholecystectomy, Postoperative Pain, Respiratory Function
Conditions
Keywords
Erector Spinae Block, Laparoscopy, Respiratory Function
Brief summary
The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.
Interventions
PROCEDUREBilateral Erector Spinae Block
A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).
OTHERControl
Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.
Sponsors
Konya Meram State Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy
Exclusion criteria
* Patients refusal * Contraindications for regional anesthesia * Alcohol or drug abuse * Chronic opioid intake * Patient with psychiatric disorders * Use of pain killers within the 24 h before the operation * Respiratory tract infection within the last 2 weeks * Smoker or history of smoking * Allergy to local anesthetics * Respiratory and allergic diseases * Cardiac disease associated with dyspnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scoring of postoperative pain | Postoperative 24 hour | The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | Postoperative 24 hour | Total opioid consumption after the operation |
| Spirometric Parameters of Respiratory Functions | Preoperative (before the surgery) and at postoperative 24th hour | Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR) |
| Number of Adverse events | Postoperative 24 hour | Postoperative nausea and vomiting incidents at PACU and and at ward. |
Countries
Turkey (Türkiye)
Outcome results
None listed