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

Knee Arthroscopic Surgery Clinical Trial

Official title:

Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847792
• Other study ID #: MS/18.09.306
• Status: Completed
• Phase: N/A
• Start date: March 31, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroscopic Surgery
• Pain, Postoperative

Intervention

Drug:
• Group DB/Dexamethasone-Bupivacaine
The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
• Group FB /Fentanyl-Bupivacaine
The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
• Group PB/Placebo-Bupivacaine
Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	Eastern
Egypt	Mohamed A Sultan	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia	Time to the first request of pethidine in minutes within the first 24 hours postoperatively	for 24 hour after surgery
Secondary	Total analgesic requirement	Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery	for 24 hour after surgery
Secondary	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.	At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Secondary	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.	At 1,2,4,6,8,12,18 and 24 hours postoperatively.
Secondary	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	measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.
Secondary	Patients' satisfaction	satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.	for 24 hour after surgery