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Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Primary Purpose

Analgesia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

Fentanyl

Bupivacain

About this trial

This is an interventional treatment trial for Analgesia focused on measuring dexmedetomidine, fentanyl, bupivacaine, knee arthroscopy, postoperative analgesia

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Either sex,
Age 21-45 years,
American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.

Exclusion Criteria:

The patients with history of hepatic and renal diseases, psychiatric disorders,
Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),
Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

Sites / Locations

Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

group B

group BD

group BF

Arm Description

IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline

. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

Outcomes

Primary Outcome Measures

Duration of postoperative analgesia

start from intra-articular injection of the drug to the time of first request of analgesia

Secondary Outcome Measures

total dose of rescue analgesia ( pethidine)

total consumption of rescue analgesia (pethidine) postoperative

The number of participants with bradycardia, itching and hypotension

The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )

patient satisfaction

Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity at rest (static)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

pain intensity on mobilization of operated knee (dynamic)

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Full Information

NCT ID

NCT04442906

First Posted

June 19, 2020

Last Updated

January 20, 2021

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT04442906

Brief Title

Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Official Title

Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

November 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.

Detailed Description

Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug). Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.

6. Conditions and Keywords

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

Analgesia

Keywords

dexmedetomidine, fentanyl, bupivacaine, knee arthroscopy, postoperative analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine

Masking

ParticipantOutcomes Assessor

Masking Description

anesthetist not sharing in the study will assess patient

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group B

Arm Type

Active Comparator

Arm Description

IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline

Arm Title

group BD

Arm Type

Active Comparator

Arm Description

. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Arm Title

group BF

Arm Type

Active Comparator

Arm Description

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

precedex

Intervention Description

Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)

Intervention Type

Drug

Intervention Name(s)

Bupivacain

Other Intervention Name(s)

marcaine

Intervention Description

Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.

Primary Outcome Measure Information:

Title

Duration of postoperative analgesia

Description

start from intra-articular injection of the drug to the time of first request of analgesia

Time Frame

For 24 hours postoperative

Secondary Outcome Measure Information:

Title

total dose of rescue analgesia ( pethidine)

Description

total consumption of rescue analgesia (pethidine) postoperative

Time Frame

within 24 hours postoperative

Title

The number of participants with bradycardia, itching and hypotension

Description

The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )

Time Frame

Within 24 hours postoperative

Title

patient satisfaction

Description

Time Frame

within 24 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)

Time Frame

measured immediately preoperative 0 minute ( admission receiving area)

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 30 minutes postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 1 hour postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 2 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 4 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 6 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 8 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 12 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 18 hours postoperative

Title

pain intensity at rest (static)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 24 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

measured immediately preoperative 0 minute ( admission receiving area)

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 30 minutes postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 1 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 2 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 4 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 6 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 8 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 12 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 18 hours postoperative

Title

pain intensity on mobilization of operated knee (dynamic)

Description

measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Time Frame

at 24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Either sex, Age 21-45 years, American Society of Anesthesia (ASA) I - II for elective knee arthroscopy. Exclusion Criteria: The patients with history of hepatic and renal diseases, psychiatric disorders, Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant), Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Salem, MD.

Organizational Affiliation

faculty of medicine , Zagazig University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zagazig university

City

Zagazig

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

34704709

Citation

Salem DAE, Nabi SMA, Alagamy SA, Kamel AAF. Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intraarticular Bupivacaine for Postoperative Analgesia after Knee Arthroscopy. Pain Physician. 2021 Nov;24(7):E989-E996.

Results Reference

derived

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Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

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