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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-14

Study Completion Date

2018-02-28

Brief Summary

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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

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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)

Study Groups

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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

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

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

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

lidocaine, bupivacaine, hyaluronidase , saline

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

lidocaine, bupivacaine, hyaluronidase , saline

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

Intervention Type DRUG

lidocaine, bupivacaine , hyaluronidase

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes