Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Pain control
Study Overview
Brief Summary
Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Levobupivacaine and tramadol Preemptive
20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
Intervention: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
Tramadol and levobupivacaine postoperative
20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.
Intervention: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
Tramadol and levobupivacaine preemptive and postoperative
20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.
Intervention: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
Levobupivacaine
20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.
Intervention: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
Outcomes
Primary Outcomes
Pain control
Time Frame: Pain assessment for 12 hours postoperative
Pain sensation after arthroscopy assessed by numeric rating scale depending upon patient facial appearance with severe patient expressing high score and no pain with lowest score
Secondary Outcomes
No secondary outcomes reported
Investigators
Ayman Anis Metry
Assistant professor
Ain Shams University