Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Summary

Intravenous regional anesthesia (IVRA) is used in outpatient hand surgery as an easily applicable and cost-effective technique with clinical advantages. Nevertheless, IVRA has some disadvantages including anesthetic toxicity, slow-onset, poor muscle relaxation, tourniquet pain, and minimal postoperative pain relief. Providing an ideal anesthesia by overcoming these disadvantages is possible with the addition of some adjunct agents into local anesthetic substances. One of these adjunct agents used for IVRA is tramadol, a synthetic analgesic having opioid and nonopioid characteristics. The present study aimed to investigate the effects of addition of systemic tramadol or adjunct tramadol to lidocaine for IVRA in patients undergoing hand surgery..

Conditions

• Anesthesia

Interventions

DRUG

Lidocaine

DRUG

lidocaine+adjunct tramadol

IVRA was performed with 3 mg/kg lidocaine (10% Lidocaine) plus 50 mg tramadol, which were administered after diluting with saline to 40 mL. While performing IVRA, 30 mL saline was simultaneously administered to the systemic circulation

DRUG

lidocaine+systemic tramadol

IVRA was performed with 3 mg/kg lidocaine, which was diluted with saline to 40 mL. While performing IVRA, 50 mg tramadol diluted with saline to 30 mL was simultaneously administered to the systemic circulation

DRUG

Fentanyl

If the patient had a VAS score of \>4 and if required, 1 μg/kg fentanyl was administered for analgesia and the dosage and time were recorded.

DRUG

Atropine

The patients received premedication 45 min before the surgery with intramuscular 0.01 mg/kg atropine. In case of bradycardia (HR \<50/min), 0.5 mg intravenous atropine was administered.

DRUG

Midazolam

The patients received premedication 45 min before the surgery with intramuscular 0.07 mg/kg midazolam

DRUG

Diclofenac sodium

The patients with a VAS score of \>4 were administered with 75 mg diclofenac sodium via intramuscular route.

DRUG

Ephedrine

In the event of hypotension (systolic arterial pressure \<90 mmHg or a decrease of more than 50 mmHg from the normal value) during the surgery, 5 mg intravenous ephedrine was administered.

DRUG

Ondansetron

Intravenous 4 mg ondansetron was administered for nausea and vomiting.

Sponsors & Collaborators

• Bagcilar Training and Research Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2013-06-30

Completion

2013-08-31