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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

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

Treatments

Drug: lidocaine, bupivacaine , hyaluronidase
Drug: Nalbuphine
Drug: lidocaine, bupivacaine, hyaluronidase , saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03436836
N-93-2017

Details and patient eligibility

About

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

Full 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

Enrollment

40 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Group N
Experimental group
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
Treatment:
Drug: Nalbuphine
Drug: lidocaine, bupivacaine , hyaluronidase
Group C
Active Comparator group
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
Treatment:
Drug: lidocaine, bupivacaine, hyaluronidase , saline

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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