Skip to main content
OpenTrials
Completed

NCT Number: NCT03847792

Analgesic Effect Of Intra-articular Bupivacaine Fentanyl 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Arthroscopic Surgery

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed A Sultan, Al Mansurah, DK, Egypt

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group DB/Dexamethasone-Bupivacaine

Drug

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

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 PB/Placebo-Bupivacaine

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.