Analgesia, Erector Spinae Plane Block, Ketamine, Spinal Decompression
Conditions
Brief summary
The aim of this study is to compare the quality of recovery of the erector spinae plane block (ESPB) versus ketamine-based multimodal analgesia regimen after spine decompressive surgery.
Detailed description
Preoperatively, standard monitors will be attached (electrocardiogram, noninvasive blood pressure, and pulse oximetry) and intravenous access will be obtained. Dexamethasone will be administered at dose of 4 mg as an antiemetic prophylaxis. Thirty min before induction of anesthesia all patients will receive 15 mg ketorolac and 1 gm paracetamol intravenously. General anesthesia will be induced by 1 mcg/kg fentanyl and 2 mg/kg propofol titrated till loss of verbal response. Tracheal intubation will be facilitated by 0.5 mg/kg atracurium. General anesthesia will be maintained by isoflurane (end-tidal isoflurane concentration of 1-1.2%) in air-oxygen admixture. Fentanyl boluses of 50 mcg will be given in case of inadequate analgesia (heart rate and or systolic blood pressure increase by 20% from the baseline in absence of other causes) Intraoperative hemodynamic management will be according to the discretion of the attending anesthetist. Postoperatively, all Patients will receive oral 1 gm of paracetamol every 6 h and 400 mg ibuprofen every 8 h. Pain assessments using NRS (Numerical Rating Scale) at rest and during movement at 0.5 , 4, 10, 18 and 24 h postoperatively. If NRS score is \> 3, intravenous 2 mg bolus of morphine will be given. Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs. At the end of 24 h postoperatively, patient's quality of recovery will be assessed using QoR-15 questionnaire and patient's satisfaction.
Interventions
DRUGketamine
after induction of anesthesia, patients will receive ketamine bolus of 0.5 mL/kg followed by continuous infusion of 0.12 mL/k/hr until the end of surgical procedure.
OTHERErector Spinae Plane Block
after induction of anesthesia, patients will receive ultrasound guided ESPB. A total of 40 mL of 0.25% bupivacaine will be injected bilaterally at the level of transverse process opposing to the mid-point of the planned incision.
OTHERWound infiltration
wound infiltration at the end of the surgery before the closure of fascia and subcutaneous tissues using a total of 20 ml of 0.25% bupivacaine
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) status of I-III * scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion.
Exclusion criteria
* Refusal to participate * Contraindication for peripheral regional anesthesia such as infection and coagulopathy. * Inability to comprehend the Numeric Rating Scale (NRS) or Patients who has cognitive function impairment * Preoperative renal or hepatic insufficiency * History of Opioid abuse. * Allergy to any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of recovery | 24 hour to 25 hour after surgery | using the QoR-15 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain assessment | 30 minutes postoperatively till 24 hours postoperatively | numerical rating scale |
| nalbuphine requirement | 30 minutes postoperatively till 24 hours postoperatively | mg |
| time to rescue analgesia | 30 minutes postoperatively till 24 hours postoperatively | hours |
Countries
Egypt
Outcome results
None listed