Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
Conditions
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
Interventions
DRUGNalbuphine
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
DRUGlidocaine, bupivacaine, hyaluronidase , saline
lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).
DRUGlidocaine, bupivacaine , hyaluronidase
2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
Sponsors
Mohamed, Ahmed A., M.D.
Nadia Yossif Helmy
Ahmed Elbadawy Mahmoud
Abdelhamid, Bassant Mohamed, M.D.
Atef Kamel Salama
Mostafa Abdalwahab Elberry
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
The enrolled patients were randomized according to computer-generated random number into two equal groups of twenty two patients each and concealed using sequentially numbered sealed opaque envelopes. 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)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory block | 12 hours Postoperative | Duration of the sensory block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor block | 12 hours Postoperative | Duration of the motor block |
| Sensory block onset | 12 hours Postoperative | Onset of the sensory block |
| Mean Arterial blood pressure | 24 hours postoperatively | Hemodynamic parameter as mean blood pressure(mmHg) |
| 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 |
Countries
Egypt
Outcome results
None listed