Clinical trial NCT03847792: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroscopic Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: for 24 hour after surgery
Secondary outcomes:
measure: Total analgesic requirement
timeFrame: for 24 hour after surgery
measure: Mean arterial blood pressure
timeFrame: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
measure: Heart rate
timeFrame: At 1,2,4,6,8,12,18 and 24 hours postoperatively.
measure: Pain score
timeFrame: measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.
measure: Patients' satisfaction
timeFrame: for 24 hour after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mohamed A Sultan
state: DK
city: Mansourah
country: Egypt
facility: Mansoura University
state: Eastern
Study officials:
affiliation: Professor of Anaesthesia and Surgical Intensive Care
name: Mohamed M Sultan, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anaesthesia and Surgical Intensive Care
name: Hazem ESM Weheba, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of Anaesthesia and Surgical Intensive Care
name: Hosam Ibrahim EL said saber, MD
role: STUDY_DIRECTOR
References: