The primary aim of this prospective, randomized study is to evaluate the effect of erector spinae block (ESP) on quality of recovery with the QoR-40 questionnaire in patients undergoing elective laparoscopic cholecystectomy.
Full Title of Study: “Evaluation of Postoperative Pain and Recovery Quality (QoR-40) in Patients Undergoing Erector Spinal Area (ESP) Block After Laparoscopic Cholecystectomy”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: March 20, 2020
Laparoscopic cholecystectomy, one of the most common general surgical procedures, is the gold standard for the treatment of symptomatic gallbladder diseases. Although it is considered as minimally invasive surgery, pain in the early postoperative period is still meaningful. Proper pain control is essential for optimizing clinical outcomes and earlier ambulation after surgery. Traditional pain management with opioids provide good pain control, however, have undesirable side effects such as nausea, vomiting, and respiratory depression. Multimodal analgesia strategies with different classes of analgesics or local anesthetics may enhance pain relief and reduce side effects after surgery. The ESP a newer regional nerve blockade, has been used as part of a multimodal strategy to optimize postoperative pain control. The primary aim of this study is to evaluate the effect of ESP block on postoperative recovery quality in patients undergoing laparoscopic cholecystectomy with QoR-40 recovery questionnaire. Secondary aim is to assess the effect of ESP block on postoperative pain, nausea, and vomiting.
Study hypothesize is that patients who receive an ESP block in addition to the current standard of care, consisting of parenteral opioids and paracetamol, will have a clinically significant improvement in their QoR-40 at postoperative day 1 and lower pain levels, as measured by NRS in comparison to those patients who receive the current standard of care along.
- Other: local anesthetic injection
- A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic mixture will be injected bilaterally 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).
- Other: Standard perioperative and postoperative analgesia protocol.
- 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 contramal 1 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.
Arms, Groups and Cohorts
- Experimental: ESP Group
- In addition to routine standard perioperative and postoperative analgesia protocol patients will receive a single shot of local anesthetic injection at the erector spinae plane.
- Other: Control
- Patients will receive standard perioperative and postoperative analgesia protocol.
Clinical Trial Outcome Measures
- Quality of Recovery (QoR-40) score
- Time Frame: postoperative 24 hour
- QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.
- Postoperative pain: numeric rating scale (NRS)
- Time Frame: Postoperative 24 hours
- NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
- Analgesic consumption
- Time Frame: Postoperative 24 hour
- Total opioid consumption after the surgery
Participating in This Clinical Trial
- American Society of Anesthesiology (ASA) physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- a history of allergy to local anesthetics
- known coagulation disorders
- infection near the puncture site
- Chronic opioid intake
- Patient with psychiatric disorders
- inability to communicate
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Konya Training and Research Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Betul Kozanhan, Ass.Prof. – Konya Training and Research Hospital
- Overall Official(s)
- Ahmet Canıtez, Principal Investigator, M.D.
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