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Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery

Primary Purpose

Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine
lidocaine, bupivacaine, hyaluronidase , saline
lidocaine, bupivacaine , hyaluronidase
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients aged 40-60 years.
  • both sex.
  • ASA physical status Ι&II.
  • Patient with axial globe length below 26

Exclusion Criteria:

  • Refusal of the patient to participate in the study.
  • Coagulation abnormalities(INR>1.4).
  • More than ASA II.
  • High myopia with axial length more than 26 mm.
  • Mentally retarded patients and failure of proper communication as in deafness .
  • Morbidly obese patients(BMI>35)
  • Patients with glaucoma (increased IOP>20mmgh)
  • Patients with history of hypersensitivity to study drugs

Sites / Locations

  • Ahmed Abdalla Mohamed
  • Ahmed Abdalla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group N

Group C

Arm Description

group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study

Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline

Outcomes

Primary Outcome Measures

Sensory block
Duration of the sensory block

Secondary Outcome Measures

Motor block
Duration of the motor block
Sensory block onset
Onset of the sensory block
Mean Arterial blood pressure
Hemodynamic parameter as mean blood pressure(mmHg)
Adverse effects of the used drugs
Adverse effects of the used drugs as nausea and vomiting
Satisfaction assessed at the end of surgical procedure by using a three-point scale
Patient satisfaction and surgeon satisfaction

Full Information

First Posted
December 30, 2017
Last Updated
May 29, 2018
Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Nadia Yossif Helmy, Ahmed Elbadawy Mahmoud, Abdelhamid, Bassant Mohamed, M.D., Atef Kamel Salama, Mostafa Abdalwahab Elberry
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1. Study Identification

Unique Protocol Identification Number
NCT03436836
Brief Title
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery
Official Title
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Nadia Yossif Helmy, Ahmed Elbadawy Mahmoud, Abdelhamid, Bassant Mohamed, M.D., Atef Kamel Salama, Mostafa Abdalwahab Elberry

4. Oversight

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

5. Study Description

Brief Summary
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal, epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia.The aim of this study is evaluation of the effect of nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery
Detailed Description
44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml). Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Forty-four patients were enrolled in the current study and randomly allocated into two equal groups [Group N (n=22) and Group C (n=22)]. Two patients in Group N and three patients in Group C were excluded from the study due to failure of the block to achieve satisfactory surgical condition (inadequate akinesia OMS>2) so, received additional supplementations 2-3 ml of LA mixture and were excluded from the study
Masking
ParticipantCare Provider
Masking Description
The enrolled patients were randomized according to computer-generated random number into two equal groups of twenty two patients each and concealed using sequentially numbered sealed opaque envelopes. Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU) , and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group N
Arm Type
Experimental
Arm Description
group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
Both groups received 8 ml solution for the peribulbar block, Patients of group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)(16) and 4mg of nalbuphine in 1 ml normal saline. Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study. After adequate analgesia (loss of sensation to touch by a small cotton wool) and akinesia, the surgeon was allowed to start the surgery
Intervention Type
Drug
Intervention Name(s)
lidocaine, bupivacaine, hyaluronidase , saline
Intervention Description
lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).
Intervention Type
Drug
Intervention Name(s)
lidocaine, bupivacaine , hyaluronidase
Intervention Description
2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
Primary Outcome Measure Information:
Title
Sensory block
Description
Duration of the sensory block
Time Frame
12 hours Postoperative
Secondary Outcome Measure Information:
Title
Motor block
Description
Duration of the motor block
Time Frame
12 hours Postoperative
Title
Sensory block onset
Description
Onset of the sensory block
Time Frame
12 hours Postoperative
Title
Mean Arterial blood pressure
Description
Hemodynamic parameter as mean blood pressure(mmHg)
Time Frame
24 hours postoperatively
Title
Adverse effects of the used drugs
Description
Adverse effects of the used drugs as nausea and vomiting
Time Frame
24 hours postoperatively
Title
Satisfaction assessed at the end of surgical procedure by using a three-point scale
Description
Patient satisfaction and surgeon satisfaction
Time Frame
6 hours Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients aged 40-60 years. both sex. ASA physical status Ι&II. Patient with axial globe length below 26 Exclusion Criteria: Refusal of the patient to participate in the study. Coagulation abnormalities(INR>1.4). More than ASA II. High myopia with axial length more than 26 mm. Mentally retarded patients and failure of proper communication as in deafness . Morbidly obese patients(BMI>35) Patients with glaucoma (increased IOP>20mmgh) Patients with history of hypersensitivity to study drugs
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt
Facility Name
Ahmed Abdalla
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Via scholar Gate

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Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery

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