A comparative randomized study to evaluate analgesic effect of dexamethasone as an adjuvant with bupivacaine and bupivacaine alone in ultrasound guided supra-zygomatic sphenopalatine ganglion block perioperatively in patients undergoing elective head and neck cancer surgery
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To record the time required by the patient for first rescue analgesia i.e. 75mg diclofenac iv in PACU
Study Overview
Brief Summary
Inadequate treatment of postoperative pain is common in surgical patients. it has been found that approximately 40% of surgical patients exhibited moderate to severe pain during the first 24 hours postoperatively in a general setting. extensive maxillofacial surgery and patients with cancer may have chronic pain and baseline opioid requirement, making perioperative analgesia management more challenging. Sphenopalatine ganglion blockade is commonly utilized to manage chronic pain syndromes like trigeminal neuralgia, headaches. one the most recently described approaches for SPGB is via ultrasound guided technique. it is a safer technique because maxillary artery is visualised in all cases. we planned our study to evaluate the hypothesis that USG guided supra-zygomatic unilateral SPGB with local anesthesia and adjuvant under general anesthesia could have a longer perioperative analgesia effect, better hemodynamics characteristics, lesser popstoperative nausea and vomiting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA physical status I-II patients, Aged 18–65 years, Patients scheduled for elective head and neck cancer surgery (involving dissection in area of maxilla, palate, retromolar trigone, anterior part of tongue, buccal mucosa) under general anaesthesia.
Exclusion Criteria
- •Patient refusal to participate, Patients who are allergic to local anaesthetics, Patient who require awake fibreoptic intubation, Patients with disfigurement and disturbed anatomy prevented easy access to the sphenopalatine ganglion, Patient who require PMMC flap and or free flap in their management, Those patient who require mechanical ventilation in postoperative stay, Those patients who will be tracheostomized during peri-operative period, History of bleeding disorders, or receiving anticoagulant therapy were excluded, Patients with a history of hepatic, renal, or cardiopulmonary dysfunction.
Outcomes
Primary Outcomes
To record the time required by the patient for first rescue analgesia i.e. 75mg diclofenac iv in PACU
Time Frame: At PACU at 30min, 1h, 2h, 6h, 10h, 14h, 18h, 24h and 48 hours after surgery
Secondary Outcomes
- Assessment of intraoperative hemodynamic parameters( HR, MAP, SpO2) at 30 min after induction till extubation of patient(2. Assessment of total perioperative opioid consumption)
Investigators
Archana Gautam
Department of Anesthesia Kalyan Singh Super Speciality Cancer Institute