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NCT Number: NCT04666337

Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

Supraclavicular brachial plexus approach is an alternative technique to general anesthesia resulting in a fast onset of a reliable blockage of the brachial plexus. The use of ultrasound for the performance of supraclavicular block has become the gold standard since it enables the clinician to deposit the local anesthetic close to the nerves in real-time that improves the success rate with a safety margin. Adjuvants are added to local anesthetic in Supraclavicular Brachial Plexus Blockade to improve the quality of nerve blocks and the duration of analgesia. It should be noted that no adjuvant has been approved by the Food and Drug Administration (FDA) for the prolongation of peripheral nerve blocks

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Key information

Conditions

Acquired Deformity of Elbow Forearm Hand Wrist

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital

Aswān, 81511, Egypt

About this study

There are multiple controversies among the previous studies for the use of different opioids as adjuvants for brachial plexus blockade to improve various block characteristics. Moreover, limited studies estimate the pons and cons of tramadol versus fentanyl as co-administrator to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade.

In our study, we aim to assess the utility of fentanyl versus tramadol as co-administrator to bupivacaine in ultrasound-guided supraclavicular brachial plexus blockade in upper limb surgeries in a prospective randomized controlled fashion. The primary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on the onset and duration of sensory and motor block and the secondary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on postoperative analgesia, time of the request to rescue analgesia, postoperative analgesic consumption, and complications.

The patients were aged between 18 and 60, both gender, and the American Society of Anesthesiologists (ASA) physical status I/II. However, patients who had bleeding disorders got opioid analgesics or monoamine oxidase inhibitors before surgery, had a history of seizures, respiratory or cardiac diseases, local infections at the site where needle for the block is to be inserted, pregnant woman and in whom the block effect was partial and required supplementary anesthesia were excluded from the study.

Patients were randomly allocated into three groups for ultrasound-guided supraclavicular brachial plexus block. Randomization was established using the computer-generated closed envelopes method.

Group B (bupivacaine group): patients received 20 ml bupivacaine 0.5% plus 2 ml normal saline Group F (fentanyl group): patients received 20 ml bupivacaine 0.5% plus fentanyl (1µg/kg-2 ml) Group T (tramadol group): patients received 20 ml bupivacaine 0.5% plus tramadol (1mg/kg-2 ml)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I/II. scheduled for forearm or hand surgery

Exclusion criteria

  • bleeding disorders
  • patients who got opioid analgesics or monoamine oxidase inhibitors before surgery,
  • history of seizures, respiratory or cardiac diseases
  • local infections at the site where the needle for the block is to be inserted
  • a pregnant woman
  • the block effect was partial and required supplementary anesthesia

Treatment and study plan

ultrasound-guided supraclavicular brachial plexus blockade

Procedure

Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe. The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side. In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view. After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe. Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.

Primary outcomes

  1. Onset time of sensory block in minutes

    Time frame: 40 minutes

    After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).

  2. onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)

    Time frame: 40 minutes

    the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.

  3. Duration of sensory block in hours

    Time frame: 24 hours

    It's the time from sensory block onset to the time of restoration of sensation at the surgical site

  4. Duration of motor block in hours

    Time frame: 24 hours

    It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

Secondary outcomes

  1. Visual analog scale (VAS): the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm).

    Time frame: 24 hours

    Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block

  2. Postoperative first analgesic request time in hours

    Time frame: 24 hours

    was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.

  3. Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously

    Time frame: 24 hours

    was given when VAS ≥ 4 cm

  4. Mean blood pressure in mmHg

    Time frame: 24 hours

    was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block

  5. heart rate in beats / minute

    Time frame: 24 hours

    was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.

  6. peripheral oxygen saturation

    Time frame: 24 hours

    was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2020
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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