Analgesia in Knee Arthroscopic Surgery

NCT ID: NCT02818985

Last Updated: 2017-06-27

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-28

Brief Summary

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Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.

Detailed Description

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Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.

Dexmedetomidine

patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.

Control

patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.

Interventions

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Dexamethasone

patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.

Intervention Type DRUG

Dexmedetomidine

patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.

Intervention Type DRUG

Saline

patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for knee arthroscopy under spinal anaesthesia

Exclusion Criteria

* Diabetes Mellitus
* Contraindication to spinal anesthesia
* Patient refusal
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Seham Mohamed Moeen Ibrahim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seham M Moeen, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut Univerisity

Locations

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Seham Mohamed Moeen Ibrahim

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Moeen SM, Ramadan IK, Elkady HA. Dexamethasone and Dexmedetomidine as an Adjuvant to Intraarticular Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery: A Randomized Trial. Pain Physician. 2017 Nov;20(7):671-680.

Reference Type DERIVED
PMID: 29149146 (View on PubMed)

Other Identifiers

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SM2016

Identifier Type: -

Identifier Source: org_study_id

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