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Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture

NCT03824665 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-05-21

No results posted yet for this study

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 4 mg Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl 20 μg to LAM and LAM alone

Conditions

  • Nalbuphine,Fentanyl and Local Anesthetic Mixture

Interventions

DRUG

Nalbuphine Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline

DRUG

Fentanyl Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline

DRUG

Control Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Abdalla Mohamed, M.D · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2019-05-10
Completion
2019-05-18

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824665 on ClinicalTrials.gov