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

Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
• Intervention / Treatment: Drug: Nalbuphine; Drug: lidocaine, bupivacaine , hyaluronidase; Drug: lidocaine, bupivacaine, hyaluronidase , saline

Detailed Description

44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. 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).

Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged 40-60 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group N; 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; 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; Drug: lidocaine, bupivacaine , hyaluronidase; 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
ACTIVE_COMPARATOR: Group C; 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; lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block	Duration of the sensory block	12 hours Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor block	Duration of the motor block	12 hours Postoperative
Sensory block onset	Onset of the sensory block	12 hours Postoperative
Mean Arterial blood pressure	Hemodynamic parameter as mean blood pressure(mmHg)	24 hours postoperatively
Adverse effects of the used drugs	Adverse effects of the used drugs as nausea and vomiting	24 hours postoperatively
Satisfaction assessed at the end of surgical procedure by using a three-point scale	Patient satisfaction and surgeon satisfaction	6 hours Postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2018
• Primary Completion (ACTUAL): February 20, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: December 30, 2017
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine; Nalbuphine
• Other Study ID Numbers: N-93-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Via scholar Gate

Drug and device information, study documents

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