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

NCT03436836 | Completed DMC

• 1 other identifier: N-93-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sensory block

  Duration of the sensory block

  12 hours Postoperative

Secondary Outcomes (5)

• Motor block

  12 hours Postoperative

• Sensory block onset

  12 hours Postoperative

• Mean Arterial blood pressure

  24 hours postoperatively

• 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

Study Arms (2)

Group N

EXPERIMENTAL

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

Drug: Nalbuphine; Drug: lidocaine, bupivacaine , hyaluronidase

Group C

ACTIVE COMPARATOR

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

Drug: lidocaine, bupivacaine, hyaluronidase , saline

Interventions

Nalbuphine DRUG

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

Group N

lidocaine, bupivacaine, hyaluronidase , saline DRUG

lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).

Group C

lidocaine, bupivacaine , hyaluronidase DRUG

2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)

Group N

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Nadia Yossif Helmy: collaborator
• Ahmed Elbadawy Mahmoud: collaborator
• Abdelhamid, Bassant Mohamed, M.D.: collaborator
• Atef Kamel Salama: collaborator
• Mostafa Abdalwahab Elberry: collaborator

Study Sites (2)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Ahmed Abdalla

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Nalbuphine; Lidocaine; Bupivacaine; Hyaluronoglucosaminidase; Sodium Chloride

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Model Details: 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

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: February 19, 2018
• Study Start: January 14, 2018
• Primary Completion: February 20, 2018
• Study Completion: February 28, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)