Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

Ain Shams University

Status: Completed

Conditions: Pain After Knee Arthroscop

Treatments: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03785041

ASUH7923/16

Details and patient eligibility

About

Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy

Full description

220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25 % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain sensation. Duration till request of rescue analgesia and number of requests were recorded. Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa Satisfaction with Anesthesia Scale.

Enrollment: 220 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient physical status according to American Society of Anesthesiology (ASA) classes I-II
• Patients free of general diseases prohibiting the use of local anesthesia.

Exclusion criteria

• Patients had allergy for local anesthetics or to tramadol
• Patients have psychological or neurological disorders inducing difficulty for evaluation of pain scoring.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups

Levobupivacaine and tramadol Preemptive

Active Comparator group

Description:

20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Tramadol and levobupivacaine postoperative

Active Comparator group

Description:

20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Tramadol and levobupivacaine preemptive and postoperative

Active Comparator group

Description:

20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Levobupivacaine

Active Comparator group

Description:

20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.

Treatment:

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML