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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436836
• Other study ID #: N-93-2017
• Status: Completed
• Phase: N/A
• Start date: January 14, 2018
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients aged 40-60 years.

• both sex.

• ASA physical status ?&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

Related Conditions & MeSH terms

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

Intervention

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
• lidocaine, bupivacaine, hyaluronidase , saline
lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).
• lidocaine, bupivacaine , hyaluronidase
2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla	Cairo
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (7)

Lead Sponsor	Collaborator
Cairo University	Ahmed Abdalla Mohamed, Ahmed Elbadawy Mahmoud, Atef Kamel Salama, Bassant Mohamed Abdelhamid, Mostafa Abdalwahab Elberry, Nadia Yossif Helmy

Country where clinical trial is conducted

Egypt, 

Outcome

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