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Clinical Trials/NCT03436836
NCT03436836
Completed
Not Applicable

Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study

Cairo University2 sites in 1 country40 target enrollmentJanuary 14, 2018

Overview

Phase
Not Applicable
Intervention
Nalbuphine
Conditions
Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
Sponsor
Cairo University
Enrollment
40
Locations
2
Primary Endpoint
Sensory block
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 14, 2018
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdalla

Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Cairo University

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

Arms & Interventions

Group N

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

Intervention: Nalbuphine

Group N

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

Intervention: lidocaine, bupivacaine , hyaluronidase

Group C

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: lidocaine, bupivacaine, hyaluronidase , saline

Outcomes

Primary Outcomes

Sensory block

Time Frame: 12 hours Postoperative

Duration of the sensory block

Secondary Outcomes

  • Sensory block onset(12 hours Postoperative)
  • Adverse effects of the used drugs(24 hours postoperatively)
  • Satisfaction assessed at the end of surgical procedure by using a three-point scale(6 hours Postoperative)
  • Motor block(12 hours Postoperative)
  • Mean Arterial blood pressure(24 hours postoperatively)

Study Sites (2)

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