Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery
- Conditions
- Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
- Interventions
- Registration Number
- NCT03436836
- Lead Sponsor
- Cairo University
- 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 nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- patients aged 40-60 years.
- both sex.
- ASA physical status Ι&II.
- Patient with axial globe length below 26
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C lidocaine, bupivacaine, hyaluronidase , 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 Group N lidocaine, bupivacaine , hyaluronidase 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 Group N Nalbuphine 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
- Primary Outcome Measures
Name Time Method Sensory block 12 hours Postoperative Duration of the sensory block
- Secondary Outcome Measures
Name Time Method Sensory block onset 12 hours Postoperative Onset of the sensory block
Adverse effects of the used drugs 24 hours postoperatively Adverse effects of the used drugs as nausea and vomiting
Satisfaction assessed at the end of surgical procedure by using a three-point scale 6 hours Postoperative Patient satisfaction and surgeon satisfaction
Motor block 12 hours Postoperative Duration of the motor block
Mean Arterial blood pressure 24 hours postoperatively Hemodynamic parameter as mean blood pressure(mmHg)
Trial Locations
- Locations (2)
Ahmed Abdalla Mohamed
🇪🇬Cairo, Egypt
Ahmed Abdalla
🇪🇬Cairo, Egypt