NCT02282774

Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery

Completed Phase 3 Last updated 3 November 2014

What this trial tests

Phase 3 trial testing 2% lidocaine and 0.5% bupivacaine in Subtenon Anesthesia in 80 participants. Completed.

Timeline

1 December 2013

Primary endpoint
1 June 2014

Quick facts

Lead sponsor	King Saud University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	80
Start date	1 December 2013
Primary completion	1 June 2014
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• 2% lidocaine and 0.5% bupivacaine — full drug profile →
• Sham subtenon block — full drug profile →

Conditions studied

• Subtenon Anesthesia — all drugs for Subtenon Anesthesia →

Sponsor

King Saud University

Who can join

Adults 40 to 90, any sex, with Subtenon Anesthesia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• the time to first postoperative analgesic dose
  Time frame: 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, t

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.