Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery

NCT ID: NCT02282774

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31

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.

Conditions

Subtenon Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

SB

receive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture

Group Type: EXPERIMENTAL

2% lidocaine and 0.5% bupivacaine

Intervention Type: DRUG

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

C

receive subtenon block of 4mL saline

Group Type: SHAM_COMPARATOR

Sham subtenon block

Intervention Type: DRUG

Interventions

2% 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

Intervention Type: DRUG

Sham subtenon block

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Marwan Abouammoh

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwan Abouammoh, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

King Abdulaziz University Hospital at King Saud University

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

E-13-968

Identifier Type: -

Identifier Source: org_study_id