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..

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jan 2013

Shorter than P25 for phase_3

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

January 1, 2013

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

2.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed

Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

December 10, 2015

Last Update Submit

January 15, 2016

Conditions

Anesthesia

Keywords

Systemic TramadolAdjunct TramadolLidocain

Outcome Measures

Primary Outcomes (4)

Onset time of sensory block
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.
The sensorial block was assessed from the injection of the study drug until the initiation of surgery by pinprick test (approximately 175 seconds)
Recovery time of sensory block
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).
The time elapsed from the deflation of tourniquet to the highest pain felt by the patient via pinprick test (approximately 135 seconds)
Onset time of motor block
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)
Recovery time of motor block
Time elapsed from the deflation of tourniquet to the spontaneous movement of the fingers (approximately 165 seconds)

Secondary Outcomes (3)

Degree of intraoperative pain
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
Degree of postoperative pain with VAS measurement
VAS measurement was performed at the postoperative 1st, 2nd, 4th, 6th, 12th and 24th hour.
Quality of anesthesia
From the initiation of surgery (30 minutes) up to 24 hours after surgery, an average of 24,5 hours

Study Arms (3)

lidocaine+adjunct tramadol

EXPERIMENTAL

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 tramadolDrug: FentanylDrug: AtropineDrug: MidazolamDrug: Diclofenac sodiumDrug: EphedrineDrug: Ondansetron

lidocaine+systemic tramadol

EXPERIMENTAL

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 tramadolDrug: FentanylDrug: AtropineDrug: MidazolamDrug: Diclofenac sodiumDrug: EphedrineDrug: Ondansetron

lidocaine

ACTIVE COMPARATOR

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

Drug: LidocaineDrug: FentanylDrug: AtropineDrug: MidazolamDrug: Diclofenac sodiumDrug: EphedrineDrug: Ondansetron

Interventions

LidocaineDRUG

lidocaine

lidocaine+adjunct tramadolDRUG

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

Also known as: tramadol

lidocaine+adjunct tramadol

lidocaine+systemic tramadolDRUG

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

Also known as: tramadol

lidocaine+systemic tramadol

FentanylDRUG

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.