Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture

NCT03824665 | Completed Phase 4 DMC

• 1 other identifier: Nalbuphine Versus Fentanyl
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Onset of eyelid and globe akinesia

  The onset of eyelid and globe akinesia was assessed till complete recovery

  24 hours Postoperative

Secondary Outcomes (3)

• Blood pressure

  24 hours Postoperative

• Heart rate

  24 hours Postoperative

• Post Operative analgesia

  24 hours Postoperative

Study Arms (3)

Nalbuphine Group

ACTIVE COMPARATOR

Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine

Drug: Nalbuphine Group

Fentanyl Group

ACTIVE COMPARATOR

Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl

Drug: Fentanyl Group

Control group

ACTIVE COMPARATOR

Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline

Drug: Control Group

Interventions

Nalbuphine Group DRUG

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

Also known as: Group N

Nalbuphine Group

Fentanyl Group DRUG

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

Also known as: Group F

Fentanyl Group

Control Group DRUG

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.

Also known as: Group C

Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 40-70 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

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients were grouped randomly using sealed envelopes prepared by an assistant who was blinded to the grouping and envelops were chosen by patient him/her self or by the nearest relative All patients received 8 ml of LAM which consisted of: 3 ml of mepivacaine 3%, 1 ml of hyaluronidase containing 150 IU, 2 ml of bupivacaine 0.5%, 1 ml of lidocaine 2%.Patients were categorized into three groups according to the type of additive used with the LAM as follows: 1. Group C (Control group): included patients assigned to receive 1 ml normal saline. 2. Group F: 1 ml saline containing 20 μg fentanyl was used instead of normal saline. 3. Group N:1 ml saline containing 4mg nalbuphine was used instead of normal saline.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 31, 2019
• Study Start: February 5, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 18, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

EG (1)