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Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery

K

King Saud University

Status and phase

Completed
Phase 3

Conditions

Subtenon Anesthesia

Treatments

Drug: 2% lidocaine and 0.5% bupivacaine
Drug: Sham subtenon block

Study type

Interventional

Funder types

Other

Identifiers

NCT02282774
E-13-968

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

SB
Experimental group
Description:
receive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture
Treatment:
Drug: 2% lidocaine and 0.5% bupivacaine
C
Sham Comparator group
Description:
receive subtenon block of 4mL saline
Treatment:
Drug: Sham subtenon block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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