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

Not Applicable

Completed

• Conditions: Knee Arthroscopic Surgery
• Interventions: Drug: Group DB/Dexamethasone-Bupivacaine; Drug: Group PB/Placebo-Bupivacaine; Drug: Group FB /Fentanyl-Bupivacaine

• Registration Number: NCT03847792
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-03-31
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group DB/Dexamethasone-Bupivacaine	Group DB/Dexamethasone-Bupivacaine	Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine
Group PB/Placebo-Bupivacaine	Group PB/Placebo-Bupivacaine	Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine
Group FB /Fentanyl-Bupivacaine	Group FB /Fentanyl-Bupivacaine	Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	for 24 hour after surgery	Time to the first request of pethidine in minutes within the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Total analgesic requirement	for 24 hour after surgery	Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
Mean arterial blood pressure	At 1,2,4,6,8,12,18 and 24 hours postoperatively.	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.
Patients' satisfaction	for 24 hour after surgery	satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.
Heart rate	At 1,2,4,6,8,12,18 and 24 hours postoperatively.	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 at 1,2,4,6,8,12,18 and 24 hours postoperatively.	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

Trial Locations

Locations (2)

Mansoura University; 🇪🇬 Mansourah, Eastern, Egypt

Mohamed A Sultan; 🇪🇬 Mansourah, DK, Egypt