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Analgesia in Knee Arthroscopic Surgery

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Dexamethasone

Dexmedetomidine

Saline

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients scheduled for knee arthroscopy under spinal anaesthesia

Exclusion Criteria:

Diabetes Mellitus
Contraindication to spinal anesthesia
Patient refusal

Sites / Locations

Seham Mohamed Moeen Ibrahim

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Dexmedetomidine

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

pain free time

VAS

Secondary Outcome Measures

Full Information

NCT ID

NCT02818985

First Posted

June 28, 2016

Last Updated

June 23, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02818985

Brief Title

Analgesia in Knee Arthroscopic Surgery

Official Title

Intra-articular Dexamethasone vs Intra-articular Dexamedetomidine

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dexmedetomidine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

pain free time

Description

VAS

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled for knee arthroscopy under spinal anaesthesia Exclusion Criteria: Diabetes Mellitus Contraindication to spinal anesthesia Patient refusal

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seham M Moeen, MD

Organizational Affiliation

Assiut Univerisity

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seham Mohamed Moeen Ibrahim

City

Asyut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29149146

Citation

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.

Results Reference

derived

Learn more about this trial

Analgesia in Knee Arthroscopic Surgery

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