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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03436836

Collaborator

Mohamed, Ahmed A., M.D. (Other), Nadia Yossif Helmy (Other), Ahmed Elbadawy Mahmoud (Other), Abdelhamid, Bassant Mohamed, M.D. (Other), Atef Kamel Salama (Other), Mostafa Abdalwahab Elberry (Other)

Enrollment

Locations

Arms

1.5

Actual Duration (Months)

Patients Per Site

13.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery	Drug: Nalbuphine Drug: lidocaine, bupivacaine, hyaluronidase , saline Drug: lidocaine, bupivacaine , hyaluronidase	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 studyForty-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 (Participant, Care Provider)

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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 14, 2018

Actual Primary Completion Date :

Feb 20, 2018

Actual Study Completion Date :

Feb 28, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group N

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

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

Drug: lidocaine, bupivacaine , hyaluronidase

2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)

Active Comparator: Group C

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

lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).

Outcome Measures

Primary Outcome Measures

Sensory block [12 hours Postoperative]
Duration of the sensory block

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdalla Mohamed	Cairo		Egypt	11451
2	Ahmed Abdalla	Cairo		Egypt	11451

Sponsors and Collaborators

Cairo University
Mohamed, Ahmed A., M.D.
Nadia Yossif Helmy
Ahmed Elbadawy Mahmoud
Abdelhamid, Bassant Mohamed, M.D.
Atef Kamel Salama
Mostafa Abdalwahab Elberry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abdalla, Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University

ClinicalTrials.gov Identifier:

NCT03436836

Other Study ID Numbers:

N-93-2017

First Posted:

Feb 19, 2018

Last Update Posted:

May 30, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2018