Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture

Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture for Peribulbar Block During Posterior Segment Surgery in Adult Patients a Prospective Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Nalbuphine,Fentanyl and Local Anesthetic Mixture
• Intervention / Treatment: Drug: Nalbuphine Group; Drug: Fentanyl Group; Drug: Control Group

Detailed Description

120 patients (40 in each group) scheduled for elective posterior chamber surgery using peribulbar block. Patients of Group N 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 F received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20 μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).

Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe akinesia, total 15-min akinesia score and duration of block.

Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.

Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops 0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for each group was injected in the medial canthus (the tunnel between the caruncle and the medial canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5 ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle directed downward and medially below the globe. Light orbital compression applied for 1 minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and chemosis.

All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP, DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged 40-70 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nalbuphine Group; 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; 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; Other Names: Group N
ACTIVE_COMPARATOR: Fentanyl Group; 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; 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; Other Names: Group F
ACTIVE_COMPARATOR: Control group; 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; 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.; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of eyelid and globe akinesia	The onset of eyelid and globe akinesia was assessed till complete recovery	24 hours Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure (mmHg) .Hypotension is defined as a 20% decrease in MAP in relation to baseline measures	24 hours Postoperative
Heart rate	Heart rate (beat/minute).Bradycardia were defined as a 20% decrease in HR in relation to baseline measures	24 hours Postoperative
Post Operative analgesia	Assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates sever pain sensation. PO analgesia was provided as if VAS was >5 in the form of I.M injection of pethidine50 mg	24 hours Postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2019
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): May 18, 2019

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Nalbuphine
• Other Study ID Numbers: Nalbuphine Versus Fentanyl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till Press

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No