Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis (TramIsch)

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Foot Fracture; Pain, Acute

Treatments: Drug: Placebo; Drug: Tramadol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03477851

WNOZA/1/2017

Details and patient eligibility

About

Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol

Full description

A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with foot fracture scheduled for surgical repair in spinal anesthesia
• Informed consent

Exclusion criteria

• No consent
• Spinal anesthesia or sciatic nerve block contraindicated
• Known intolerance to tramadol or other contraindications for the drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.

Treatment:

Drug: Placebo

Tramadol

Experimental group

Description:

Patients randomized to receive 100mg of Tramadol hydrochloride in 5ml 0,9% sodium hydrochloride i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.

Treatment:

Drug: Tramadol Hydrochloride