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Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

Primary Purpose

Acute Postoperative Pain

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
lidocaine 2%
bupivacine 0.5%
Normal saline
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Postoperative Pain focused on measuring subtenon, dexmedetomidine, cataract surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA grade I-III
  • Aged 18-70 years
  • Both sex
  • Scheduled for elective phacoemulsification cataract surgery

Exclusion Criteria:

  • Coagulation abnormalities
  • Impaired mental status
  • Refusal of the patient
  • Uncontrolled glaucoma
  • Recent surgical procedure on the same eye

Sites / Locations

  • Ashraf magdy Eskandr
  • Osama A Elmorsy
  • Sadik A Sadik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group C (control group)

Group SD (subtenon dexmedetomiine)

Group ID (iv dexmedetomidine)

Arm Description

Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.

Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.

Outcomes

Primary Outcome Measures

duration of sensory block
time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia

Secondary Outcome Measures

duration of motor block
time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.

Full Information

First Posted
December 2, 2020
Last Updated
February 23, 2021
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04668456
Brief Title
Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
Official Title
The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 14, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.
Detailed Description
Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block. The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury. Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics. Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain
Keywords
subtenon, dexmedetomidine, cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C (control group)
Arm Type
Placebo Comparator
Arm Description
Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.
Arm Title
Group SD (subtenon dexmedetomiine)
Arm Type
Active Comparator
Arm Description
Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.
Arm Title
Group ID (iv dexmedetomidine)
Arm Type
Active Comparator
Arm Description
Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
the drug administered either subtenon ot iv
Intervention Type
Drug
Intervention Name(s)
lidocaine 2%
Intervention Description
subtenon injection
Intervention Type
Drug
Intervention Name(s)
bupivacine 0.5%
Intervention Description
subtenon injection
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
either subtenon or iv
Primary Outcome Measure Information:
Title
duration of sensory block
Description
time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
duration of motor block
Description
time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA grade I-III Aged 18-70 years Both sex Scheduled for elective phacoemulsification cataract surgery Exclusion Criteria: Coagulation abnormalities Impaired mental status Refusal of the patient Uncontrolled glaucoma Recent surgical procedure on the same eye
Facility Information:
Facility Name
Ashraf magdy Eskandr
City
Shibīn Al Kawm
State/Province
Menoufiya
ZIP/Postal Code
1234
Country
Egypt
Facility Name
Osama A Elmorsy
City
Shibīn Al Kawm
State/Province
Menoufiya
ZIP/Postal Code
1234
Country
Egypt
Facility Name
Sadik A Sadik
City
Shibīn Al Kawm
State/Province
Menoufiya
ZIP/Postal Code
1234
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

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