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

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ClinicalTrials.gov Identifier: NCT02658721
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Abdulkadir Yektas, Bagcilar Training and Research Hospital

Brief 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..

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Lidocaine Drug: lidocaine+adjunct tramadol Drug: lidocaine+systemic tramadol Drug: Fentanyl Drug: Atropine Drug: Midazolam Drug: Diclofenac sodium Drug: Ephedrine Drug: Ondansetron Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Addition of Systemic Tramadol or Adjunct Tramadol to Lidocaine Used for Intravenous Regional Anesthesia in Patients Undergoing Hand Surgery
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lidocaine+adjunct tramadol
In the first group (LDC+TRA group), 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+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
Other Name: tramadol

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.

Experimental: lidocaine+systemic tramadol
In the second group (LDC+SysTRA group), 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: 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
Other Name: tramadol

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.

Active Comparator: lidocaine
In the third group (LDC group), IVRA was performed with 3 mg/kg lidocaine, which was diluted with saline to 40 mL.
Drug: Lidocaine
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.




Primary Outcome Measures :
  1. Onset time of sensory block [ Time Frame: The sensorial block was assessed from the injection of the study drug until the initiation of surgery by pinprick test (approximately 175 seconds) ]
    After the injection, the sensorial block was assessed until the initiation of surgery by pinprick test using 22 gauge needle on the radial, ulnar and median nerve stimulation areas of the hand and of the anterior surface of the arm. The time elapsed from the injection of the study drug until the sensorial block was provided in all stimulation areas was recorded as the onset time of sensorial block.

  2. Recovery time of sensory block [ Time Frame: The time elapsed from the deflation of tourniquet to the highest pain felt by the patient via pinprick test (approximately 135 seconds) ]
    The time of sensorial recovery was recorded (the time elapsed from the deflation of tourniquet to the highest pain felt by the patient via pinprick test in all stimulation areas).

  3. Onset time of motor block [ Time Frame: The time elapsed from the injection of the study drug until achieving the complete motor block was recorded as the onset time of motor block (approximately 220 seconds) ]
  4. Recovery time of motor block [ Time Frame: Time elapsed from the deflation of tourniquet to the spontaneous movement of the fingers (approximately 165 seconds) ]

Secondary Outcome Measures :
  1. Degree of intraoperative pain [ Time Frame: VAS scores were recorded before (one minute ago) and after tourniquet (five minutes later) application as well as at 5th, 10th, 15th, 20th, 30th, 40th, and 50th min during the surgery ]
    Pain level of the patients was assessed by 10 cm visual analogue scale (VAS; 0=no pain; 10=very severe pain) for once throughout the study.There is no follow up visit in the study. VAS scores were recorded before (one minute ago) and after tourniquet (five minutes later) application as well as at 5th, 10th, 15th, 20th, 30th, 40th, and 50th min during the surgery for once throughout the study.

  2. Degree of postoperative pain with VAS measurement [ Time Frame: VAS measurement was performed at the postoperative 1st, 2nd, 4th, 6th, 12th and 24th hour. ]
    The patients were monitored in the postoperative care unit for the first 2 h and then in the observation room for 24 h by anesthesiologists who were blinded to the study. VAS measurement was performed at the postoperative 1st, 2nd, 4th, 6th, 12th and 24th h for once throughout the study.There is no follow up visit in the study.

  3. Quality of anesthesia [ Time Frame: From the initiation of surgery (30 minutes) up to 24 hours after surgery, an average of 24,5 hours ]
    Quality of anesthesia is assessed as follows. 4: excellent, patient does not complain; 3: good, patient complains a little, no need for supplemental analgesic; 2: moderate, patient complains, need for supplemental analgesic; 1: failed, need for general anesthesia



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-II patients who were planned to undergo hand surgery.

Exclusion Criteria:

  • Patients with Raynaud's disease, those with sickle-cell anemia, and those receiving any drug for history of allergy

Publications:

Layout table for additonal information
Responsible Party: Abdulkadir Yektas, Dr. Abdulkadir Yektas, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02658721     History of Changes
Other Study ID Numbers: IVRA
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Abdulkadir Yektas, Bagcilar Training and Research Hospital:
Systemic Tramadol
Adjunct Tramadol
Lidocain

Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Lidocaine
Atropine
Fentanyl
Midazolam
Ondansetron
Diclofenac
Ephedrine
Pseudoephedrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs