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Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery

Primary Purpose

Knee Arthroscopic Surgery

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group DB/Dexamethasone-Bupivacaine
Group FB /Fentanyl-Bupivacaine
Group PB/Placebo-Bupivacaine
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Arthroscopic Surgery

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASA) I or II

Exclusion Criteria:

  • Contraindication to spinal anesthesia.
  • Allergy to the study drugs.
  • Refusal of the patients.

Sites / Locations

  • Mohamed A Sultan
  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group DB/Dexamethasone-Bupivacaine

Group FB /Fentanyl-Bupivacaine

Group PB/Placebo-Bupivacaine

Arm Description

Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine

Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine

Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine

Outcomes

Primary Outcome Measures

Duration of postoperative analgesia
Time to the first request of pethidine in minutes within the first 24 hours postoperatively

Secondary Outcome Measures

Total analgesic requirement
Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
Mean arterial blood pressure
Mean arterial blood pressure measured in mm Hg and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Heart rate
Heart rate will be measured in beats/minute and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Pain score
Measured with visual analogue score(VAS):0=no pain and 100=worst imaginable pain measured at 1,2,4,6,8,12,18 and 24 hours
Patients' satisfaction
satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.

Full Information

First Posted
February 19, 2019
Last Updated
September 9, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03847792
Brief Title
Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery
Official Title
Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.
Detailed Description
Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used. Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group DB/Dexamethasone-Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine
Arm Title
Group FB /Fentanyl-Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine
Arm Title
Group PB/Placebo-Bupivacaine
Arm Type
Placebo Comparator
Arm Description
Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Group DB/Dexamethasone-Bupivacaine
Intervention Description
The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
Intervention Type
Drug
Intervention Name(s)
Group FB /Fentanyl-Bupivacaine
Intervention Description
The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Group PB/Placebo-Bupivacaine
Intervention Description
Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.
Primary Outcome Measure Information:
Title
Duration of postoperative analgesia
Description
Time to the first request of pethidine in minutes within the first 24 hours postoperatively
Time Frame
for 24 hour after surgery
Secondary Outcome Measure Information:
Title
Total analgesic requirement
Description
Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
Time Frame
for 24 hour after surgery
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure measured in mm Hg and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Time Frame
At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Title
Heart rate
Description
Heart rate will be measured in beats/minute and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.
Time Frame
At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Title
Pain score
Description
Measured with visual analogue score(VAS):0=no pain and 100=worst imaginable pain measured at 1,2,4,6,8,12,18 and 24 hours
Time Frame
measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.
Title
Patients' satisfaction
Description
satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.
Time Frame
for 24 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status (ASA) I or II Exclusion Criteria: Contraindication to spinal anesthesia. Allergy to the study drugs. Refusal of the patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Sultan, MD
Organizational Affiliation
Professor of Anaesthesia and Surgical Intensive Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hazem ESM Weheba, MD
Organizational Affiliation
Assistant Professor of Anaesthesia and Surgical Intensive Care
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hosam Ibrahim EL said saber, MD
Organizational Affiliation
Lecturer of Anaesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Mohamed A Sultan
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
Facility Name
Mansoura University
City
Mansourah
State/Province
Eastern
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Following publication
IPD Sharing Time Frame
forever
IPD Sharing Access Criteria
tawfik20192@gmail.com

Learn more about this trial

Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery

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