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

• ClinicalTrials.gov Identifier: NCT03847792
• Recruitment Status: Completed
• First Posted: February 20, 2019
• Last Update Posted: September 11, 2020
• Sponsor: Mansoura University
• Information provided by (Responsible Party): Mansoura University

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.

Condition or disease	Intervention/treatment	Phase
Knee Arthroscopic Surgery	Drug: Group DB/Dexamethasone-Bupivacaine; Drug: Group FB /Fentanyl-Bupivacaine; Drug: Group PB/Placebo-Bupivacaine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Basic Science
• Official Title: Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery
• Actual Study Start Date: March 31, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Duration of postoperative analgesia [ Time Frame: for 24 hour after surgery ]
   Time to the first request of pethidine in minutes within the first 24 hours postoperatively

Secondary Outcome Measures :

1. Total analgesic requirement [ Time Frame: for 24 hour after surgery ]
   Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
2. Mean arterial blood pressure [ Time Frame: 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.
3. Heart rate [ Time Frame: 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.
4. Pain score [ Time Frame: 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
5. Patients' satisfaction [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Egypt

Mohamed A Sultan

Mansourah, DK, Egypt, 050

Mansoura University

Mansourah, Eastern, Egypt, 050

Sponsors and Collaborators

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

More Information

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT03847792
• Other Study ID Numbers: MS/18.09.306
• First Posted: February 20, 2019
• Last Update Posted: September 11, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Following publication
• Supporting Materials: Study Protocol
• Time Frame: forever
• Access Criteria: tawfik20192@gmail.com

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Dexamethasone; Fentanyl; Bupivacaine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General