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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery

Intervention / Treatment
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* Drug: Nalbuphine
* Drug: lidocaine, bupivacaine, hyaluronidase , saline
* Drug: lidocaine, bupivacaine , hyaluronidase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group N<br>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<br>* 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<br>Drug: lidocaine, bupivacaine , hyaluronidase<br>* 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)<br>|
| Active Comparator: Group C<br>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<br>* lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).<br>|

What is the study measuring?
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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 |