Loading search results

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: NalbuphineDrug: 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

NalbuphineDrug

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 , salineDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry

lidocaine, bupivacaine, hyaluronidase , saline

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

Grouped treatment entry

lidocaine, bupivacaine , hyaluronidase

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

MeSH Terms

Interventions

NalbuphineLidocaineBupivacaineHyaluronoglucosaminidaseSodium Chloride

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

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

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

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Group N

Group C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Group N

Group C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations