Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03824665

Collaborator

(none)

120

Enrollment

Location

Arms

3.4

Actual Duration (Months)

35.8

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 4 mg Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl 20 μg to LAM and LAM alone

Condition or Disease	Intervention/Treatment	Phase
Nalbuphine,Fentanyl and Local Anesthetic Mixture	Drug: Nalbuphine Group Drug: Fentanyl Group Drug: Control Group	Phase 4

Detailed Description

120 patients (40 in each group) scheduled for elective posterior chamber surgery using peribulbar block. Patients of Group N 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 F received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20 μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).

Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe akinesia, total 15-min akinesia score and duration of block.

Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.

Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops 0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for each group was injected in the medial canthus (the tunnel between the caruncle and the medial canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5 ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle directed downward and medially below the globe. Light orbital compression applied for 1 minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and chemosis.

All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP, DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.

Masking:

Double (Participant, Investigator)

Masking Description:

Patients were grouped randomly using sealed envelopes prepared by an assistant who was blinded to the grouping and envelops were chosen by patient him/her self or by the nearest relative All patients received 8 ml of LAM which consisted of: 3 ml of mepivacaine 3%, 1 ml of hyaluronidase containing 150 IU, 2 ml of bupivacaine 0.5%, 1 ml of lidocaine 2%.Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline. Group F: 1 ml saline containing 20 μg fentanyl was used instead of normal saline. Group N:1 ml saline containing 4mg nalbuphine was used instead of normal saline.

Primary Purpose:

Supportive Care

Official Title:

Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture for Peribulbar Block During Posterior Segment Surgery in Adult Patients a Prospective Randomized Clinical Trial

Actual Study Start Date :

Feb 5, 2019

Actual Primary Completion Date :

May 10, 2019

Actual Study Completion Date :

May 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nalbuphine Group Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine	Drug: Nalbuphine Group All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline Other Names: Group N
Active Comparator: Fentanyl Group Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl	Drug: Fentanyl Group All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline Other Names: Group F
Active Comparator: Control group Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline	Drug: Control Group All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline. Other Names: Group C

Arm

Intervention/Treatment

Active Comparator: Nalbuphine Group

Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine

Drug: Nalbuphine Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline

Other Names:

Group N

Active Comparator: Fentanyl Group

Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl

Drug: Fentanyl Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline

Other Names:

Group F

Active Comparator: Control group

Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline

Drug: Control Group

All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline.

Other Names:

Group C

Outcome Measures

Primary Outcome Measures

Onset of eyelid and globe akinesia [24 hours Postoperative]
The onset of eyelid and globe akinesia was assessed till complete recovery

Secondary Outcome Measures

Blood pressure [24 hours Postoperative]
Blood pressure (mmHg) .Hypotension is defined as a 20% decrease in MAP in relation to baseline measures
Heart rate [24 hours Postoperative]
Heart rate (beat/minute).Bradycardia were defined as a 20% decrease in HR in relation to baseline measures
Post Operative analgesia [24 hours Postoperative]
Assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates sever pain sensation. PO analgesia was provided as if VAS was >5 in the form of I.M injection of pethidine50 mg

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients aged 40-70 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

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed Abdalla Mohamed, M.D, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03824665

Other Study ID Numbers:

Nalbuphine Versus Fentanyl

First Posted:

Jan 31, 2019

Last Update Posted:

May 21, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Additional relevant MeSH terms:

Fentanyl

Nalbuphine

Study Results

No Results Posted as of May 21, 2019