Clinical trial NCT03436836: Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery
Official title: Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Mohamed, Ahmed A., M.D.
name: Nadia Yossif Helmy
name: Ahmed Elbadawy Mahmoud
name: Abdelhamid, Bassant Mohamed, M.D.
name: Atef Kamel Salama
name: Mostafa Abdalwahab Elberry
First posted: 2018-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Sensory block
timeFrame: 12 hours Postoperative
Secondary outcomes:
measure: Motor block
timeFrame: 12 hours Postoperative
measure: Sensory block onset
timeFrame: 12 hours Postoperative
measure: Mean Arterial blood pressure
timeFrame: 24 hours postoperatively
measure: Adverse effects of the used drugs
timeFrame: 24 hours postoperatively
measure: Satisfaction assessed at the end of surgical procedure by using a three-point scale
timeFrame: 6 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
city: Cairo
country: Egypt
facility: Ahmed Abdalla
Study officials:
References: