Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
- Conditions
- Subtenon Anesthesia
- Interventions
- Drug: Sham subtenon block
- Registration Number
- NCT02282774
- Lead Sponsor
- King Saud University
- Brief Summary
To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patient undergoing elective retinal surgery under general anesthesia
- ASA physical status > Grade II,
- psychiatric conditions,
- neurological impairment,
- deafness with whom communication would be difficult in the postoperative period,
- clotting abnormalities,
- contraindications for regional anesthesia,
- drug abuse,
- history of allergy to the study drugs,
- previous vitreoretinal or strabismus surgery,
- endophthalmitis, or inflammatory eye pathology
- taking analgesics, antiemetics or drugs that might affect hemodynamics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SB 2% lidocaine and 0.5% bupivacaine receive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture C Sham subtenon block receive subtenon block of 4mL saline
- Primary Outcome Measures
Name Time Method the time to first postoperative analgesic dose 24 hrs Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted
- Secondary Outcome Measures
Name Time Method number of patients requiring rescue analgesics during the 24-h study period during the whole study (6 months) postoperative pain scores First 24 hrs after surgery Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted.
incidence of postoperative nausea/vomiting First 24 hrs after surgery The incidence of postoperative nausea and vomiting (PONV) was assessed by a nurse (who was blinded to the study drug) for the first 2 h in the PACU and subsequently in the ward at 6, 12 and 24 h and Only 2 possible answers was accepted (yes) or (no). Nausea was defined as subjective sensation of discomfort associated with the awareness of the urge to vomit. Vomiting was defined as a forceful expulsion of gastric contents through the mouth. Rescue antiemetic (Ondansetron 0.15 mg/kg) was given if the patient had persistent nausea or more than a single episode of vomiting or whenever patients request medication and number of patients required rescue anti-emetic postoperatively were recorded
consumption of rescue analgesics during the whole study (6 months) The total number of patients receiving rescue analgesia is recorded
incidence of oculocardiac reflex during time of surgery
Trial Locations
- Locations (1)
King Abdulaziz University Hospital at King Saud University
🇸🇦Riyadh, Saudi Arabia