Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

Phase 4

Completed

• Conditions: Foot Fracture; Pain, Acute
• Interventions: Drug: Placebo; Drug: Tramadol Hydrochloride

• Registration Number: NCT03477851
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-26
• Status Verified: 2020-05
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall analgesic in 24h	24hour	Overall Morphine hydrochloride dose in the first 24h after intervention

Secondary Outcome Measures

Name	Time	Method
Time to block resolution	24hour	Time from the intervention to complete motoric block resolution
Time to first analgesic	24hour	Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride

Trial Locations

Locations (1)

Dept.of Anesthesia and Intensive Care, Warsaw Medical University; 🇵🇱 Warsaw, Mazowieckie, Poland