Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03847792
Enrollment
87
Registered
2019-02-20
Start date
2019-03-31
Completion date
2020-06-30
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroscopic Surgery

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

Interventions

DRUGGroup DB/Dexamethasone-Bupivacaine

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

DRUGGroup FB /Fentanyl-Bupivacaine

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

DRUGGroup PB/Placebo-Bupivacaine

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative analgesiafor 24 hour after surgeryTime to the first request of pethidine in minutes within the first 24 hours postoperatively

Secondary

MeasureTime frameDescription
Total analgesic requirementfor 24 hour after surgeryTotal analgesic requirement of pethidine will be recorded during the first 24 hours following surgery
Mean arterial blood pressureAt 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.
Heart rateAt 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.
Pain scoremeasured 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
Patients' satisfactionfor 24 hour after surgerysatisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026