Erector spinae muscle plane block on both side of spine using ultrasound machine for postoperative pain control in patients undergoing laparoscopic gall bladder surgery.
- Conditions
- Calculus of gallbladder without cholecystitis,
- Registration Number
- CTRI/2019/05/019184
- Lead Sponsor
- Department of Anaesthesiology
- Brief Summary
Pain is the dominating complaint and the primary reason for prolonged convalescence after laparoscopic cholecystectomy1. It has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g. Post laparoscopic cholecystectomy syndrome)2. Erector spinae plane block is a novel thoracic myofascial plane block that was reported first in 2016.3 It is a simpler and safer alternative to thoracic paravertebral and epidural blockade because the sonographic target is easily visualized and the site of injection is distant to the neuraxis and any major vascular structures and provides more extensive cranio-caudal spread with a single injection without major complications4
**Objective :** To study and compare the analgesic efficacy of single shot bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy.
**DESIGN** : Double blind , prospective, randomized controlled study
**Methodology** : A blinded anaesthetist 1 will explain about ESP block to patient and takes I/W consent in preoperative period and he will also collect the data later on.
On day of surgery anaesthetist 2 will prepare 2 syringes of 20ml 0.375% ropivacaine or normal saline as per computer generated random table and assign a number and accordingly group (1/2) to the patient.
A blinded anaesthetist 3 will give bilateral ESP block with 20 ml of drug each side under USG guidance after induction of anaesthesia.
Anaesthetist 1 will manage case as per protocol with 2mcg/kg fentanyl at induction, 1mcg/kg at port insertion.
Inj. Paracetamol 1gm iv pre-emptively
Fentanyl repeated after 1 hour henceforth 1mcg/kg if needed
Inj. Paracetamol 1 gm iv will be continued 8th hourly.
Rescue analgesic in postoperative period (when the VAS > 4) : Inj. Diclofenac 75mg iv
**References :**
1. *Bisgaard T, Klarskov B, Rosenberg J, Kehlet H: Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg 2001; 136:917–21*
2. *Bisgaard T, Rosenberg J, Kehlet H: From acute to chronic pain after laparoscopic cholecystectomy: A prospective follow-up analysis. Scand J Gastroenterol 2005; 40:1358–64*
3. *Forero M, Adhikary SD, Lopez H, et al. The erector spinae plane block: A novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med 2016;41:621–7*
4. *Forero M, Rajarathinam M, Adhikary S, et al. Continuous erector spinae plane block for rescue analgesia in thoracotomy after epidural failure: A case report. A A Case Rep 2017;8:254–6*
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 84
ASA I and II patients, Undergoing elective laparoscopic cholecystectomy under general anaesthesia.
Patients with contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, psychiatric disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative pain using a visual analog scale (VAS) in both groups at rest and dynamic pain on coughing. 0 (at arrival in postoperative ICU), 1, 6, 12, 24 hours
- Secondary Outcome Measures
Name Time Method Total need for rescue analgesic in postoperative period 24 hrs postoperatively Intraoperative total fentanyl consumption At the end of surgery Time to ambulation of patient At 6hrs, 12hrs, 18hrs or 24 hours.
Trial Locations
- Locations (1)
Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences🇮🇳Lucknow, UTTAR PRADESH, IndiaRuchi VermaPrincipal investigator9415590425ruchiv197@gmail.com