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

NCT03847792 | Completed DMC

• 1 other identifier: MS/18.09.306
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Arthroscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total analgesic requirement

  for 24 hour after surgery

• Mean arterial blood pressure

  At 1,2,4,6,8,12,18 and 24 hours postoperatively.

• Heart rate

  At 1,2,4,6,8,12,18 and 24 hours postoperatively.

• Pain score

  measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.

• Patients' satisfaction

  for 24 hour after surgery

Study Arms (3)

Group DB/Dexamethasone-Bupivacaine

ACTIVE COMPARATOR

Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine

Drug: Group DB/Dexamethasone-Bupivacaine

Group FB /Fentanyl-Bupivacaine

ACTIVE COMPARATOR

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

Group PB/Placebo-Bupivacaine

PLACEBO COMPARATOR

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

Interventions

Group DB/Dexamethasone-Bupivacaine DRUG

The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.

Group DB/Dexamethasone-Bupivacaine

Group FB /Fentanyl-Bupivacaine DRUG

The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.

Group FB /Fentanyl-Bupivacaine

Group PB/Placebo-Bupivacaine DRUG

Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.

Group PB/Placebo-Bupivacaine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Mohamed A Sultan

Al Mansurah, DK, 050, Egypt

Location

Mansoura University

Al Mansurah, Eastern, 050, Egypt

Location

Study Officials

• Mohamed M Sultan, MD

  Professor of Anaesthesia and Surgical Intensive Care

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: March 31, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: forever
• Access Criteria: tawfik20192@gmail.com

Locations

EG (2)