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Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02282774
Enrollment
80
Registered
2014-11-04
Start date
2013-12-31
Completion date
Unknown
Last updated
2014-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subtenon Anesthesia

Keywords

Vitreoretinal surgery

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.

Interventions

DRUG2% lidocaine and 0.5% bupivacaine

Under general anesthesia and the operating microscope, a Lieberman lid speculum was placed and the conjunctiva was cleaned with 4% povidone iodine solution. The surgeon then created a fornix-based incision through conjunctiva and tenon's tissue inferonasally midway between the insertions of the medial and inferior rectus muscles, with blunt Wescott scissors to expose the scleral surface before tunneling posteriorly with curved Stevens scissors to create a small channel to the posterior subtenon space. A blunt-tipped subtenon cannula was then inserted into the posterior subtenon space, 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture versus saline was introduced and the drug solution was injected slowly into the subtenon space. After administration of local anesthetic mixture, the eyelid was gently taped down, and no ocular massage was performed

DRUGSham subtenon block

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patient undergoing elective retinal surgery under general anesthesia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
the time to first postoperative analgesic dose24 hrsPain 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

MeasureTime frameDescription
postoperative pain scoresFirst 24 hrs after surgeryPain 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.
number of patients requiring rescue analgesics during the 24-h study periodduring the whole study (6 months)
consumption of rescue analgesicsduring the whole study (6 months)The total number of patients receiving rescue analgesia is recorded
incidence of oculocardiac reflexduring time of surgery
incidence of postoperative nausea/vomitingFirst 24 hrs after surgeryThe 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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026