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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroscopic Surgery
• Intervention / Treatment: Drug: Group DB/Dexamethasone-Bupivacaine; Drug: Group FB /Fentanyl-Bupivacaine; Drug: Group PB/Placebo-Bupivacaine

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

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mohamed A Sultan
  • Eastern
    • Mansourah, Eastern, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group DB/Dexamethasone-Bupivacaine; Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine	Drug: Group DB/Dexamethasone-Bupivacaine; The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
Active Comparator: Group FB /Fentanyl-Bupivacaine; Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine	Drug: Group FB /Fentanyl-Bupivacaine; The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
Placebo Comparator: Group PB/Placebo-Bupivacaine; Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine	Drug: Group PB/Placebo-Bupivacaine; Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic requirement	Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery	for 24 hour after 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.	At 1,2,4,6,8,12,18 and 24 hours postoperatively.
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.
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.
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed M Sultan, MD, Professor of Anaesthesia and Surgical Intensive Care; Study Director: Hazem ESM Weheba, MD, Assistant Professor of Anaesthesia and Surgical Intensive Care; Study Director: Hosam Ibrahim EL said saber, MD, Lecturer of Anaesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Dexamethasone; Fentanyl; Bupivacaine
• Other Study ID Numbers: MS/18.09.306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following publication
• IPD Sharing Time Frame: forever
• IPD Sharing Access Criteria: tawfik20192@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No