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Midazolam Additive to Local Anesthetic in Peribulbar Block

Primary Purpose

Postoperative Pain, Cataract, Local Anaesthetic Complication

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Peribulbar block (control)
Peribulbar block(M1)
Peribulbar block(M2)
Sponsored by
Al Jedaani Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring peribubar block - midazolam

Eligibility Criteria

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

Inclusion Criteria:

  • 90 adult patients with ASA physical status I to III
  • Aged 40-70 years
  • Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block
  • No history of allergy to local anesthetics
  • Axial length less than 28 mm.

Exclusion Criteria:

  • Patient's refusal to share in the study
  • communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)
  • uncontrolled tremors
  • morbidly obese patients
  • allergy to lidocaine
  • coagulation abnormalities
  • glaucoma
  • recent surgical procedure on the same eye.

Sites / Locations

  • Al Jedaani group of hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group C(control)

Group M1

Group M2

Arm Description

Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)

Peribulbar block with midazolam 50 µg (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml)

Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml

Outcomes

Primary Outcome Measures

Quality of the sensory and motor block
The quality of the sensory and motor block was assessed using the Ocular Anesthesia Scoring System (OASS). Patients were categorized into three groups according to the quality of the block and level of anesthesia achieved: poor (0-3), average (4-9) and good block (10-14)

Secondary Outcome Measures

Onset and duration of block
The onset of motor block (globe akinesia), sensory block, and lid akinesia (ptosis). Were recorded from the time of injection of (LAS) until complete globe akinesia, a disappearance of sensation, and complete lid akinesia (ptosis). Duration of globe akinesia was recorded till recurrence of muscle movements (score 8). Similarly, the return of sensation to the globe was assessed by digital spear pressure at the limbus.
Analgesia
Postoperative pain was assessed at 30 minutes' intervals utilizing verbal rating scale (VAS) on a scale of 0 to 10 (where 0 means no pain and 10 means the worst imaginable pain) for a period of 4 hours postoperative or until first analgesic request
local or systemic complications
sub-conjunctival hematoma, itching, ecchymosis, diplopia, blindness, nausea, vomiting, dry mouth, and hypotension, were recorded.

Full Information

First Posted
December 23, 2017
Last Updated
August 10, 2018
Sponsor
Al Jedaani Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03397069
Brief Title
Midazolam Additive to Local Anesthetic in Peribulbar Block
Official Title
Efficacy of Midazolam Addition to Local Anesthetic in Peribulbar Block. Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al Jedaani Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex. The investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cataract, Local Anaesthetic Complication, Midazolam
Keywords
peribubar block - midazolam

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C(control)
Arm Type
Placebo Comparator
Arm Description
Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)
Arm Title
Group M1
Arm Type
Experimental
Arm Description
Peribulbar block with midazolam 50 µg (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml)
Arm Title
Group M2
Arm Type
Experimental
Arm Description
Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml
Intervention Type
Procedure
Intervention Name(s)
Peribulbar block (control)
Other Intervention Name(s)
Peribulbar block without midazolam
Intervention Description
The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.
Intervention Type
Procedure
Intervention Name(s)
Peribulbar block(M1)
Other Intervention Name(s)
Peribulbar block with midazolam 50ug
Intervention Description
The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.
Intervention Type
Procedure
Intervention Name(s)
Peribulbar block(M2)
Other Intervention Name(s)
Peribulbar block with midazolam 100ug
Intervention Description
The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.
Primary Outcome Measure Information:
Title
Quality of the sensory and motor block
Description
The quality of the sensory and motor block was assessed using the Ocular Anesthesia Scoring System (OASS). Patients were categorized into three groups according to the quality of the block and level of anesthesia achieved: poor (0-3), average (4-9) and good block (10-14)
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Onset and duration of block
Description
The onset of motor block (globe akinesia), sensory block, and lid akinesia (ptosis). Were recorded from the time of injection of (LAS) until complete globe akinesia, a disappearance of sensation, and complete lid akinesia (ptosis). Duration of globe akinesia was recorded till recurrence of muscle movements (score 8). Similarly, the return of sensation to the globe was assessed by digital spear pressure at the limbus.
Time Frame
6 hours
Title
Analgesia
Description
Postoperative pain was assessed at 30 minutes' intervals utilizing verbal rating scale (VAS) on a scale of 0 to 10 (where 0 means no pain and 10 means the worst imaginable pain) for a period of 4 hours postoperative or until first analgesic request
Time Frame
4 hours postoperative
Title
local or systemic complications
Description
sub-conjunctival hematoma, itching, ecchymosis, diplopia, blindness, nausea, vomiting, dry mouth, and hypotension, were recorded.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 90 adult patients with ASA physical status I to III Aged 40-70 years Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block No history of allergy to local anesthetics Axial length less than 28 mm. Exclusion Criteria: Patient's refusal to share in the study communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status) uncontrolled tremors morbidly obese patients allergy to lidocaine coagulation abnormalities glaucoma recent surgical procedure on the same eye.
Facility Information:
Facility Name
Al Jedaani group of hospitals
City
Jeddah
State/Province
Meccah
ZIP/Postal Code
21462/7500
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30627737
Citation
Ibrahim M, Gomaa E. Efficacy of midazolam addition to local anesthetic in peribulbar block : Randomized controlled trial. Anaesthesist. 2019 Mar;68(3):143-151. doi: 10.1007/s00101-018-0525-3. Epub 2019 Jan 9.
Results Reference
derived

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Midazolam Additive to Local Anesthetic in Peribulbar Block

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