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Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

Primary Purpose

Acquired Deformity of Elbow, Forearm, Hand

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound-guided supraclavicular brachial plexus blockade
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Deformity of Elbow focused on measuring Supraclavicular Brachial Plexus Blockade, Fentanyl, Tramadol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aswan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group B (bupivacaine group)

Group F (fentanyl group)

Group T (tramadol group)

Arm Description

patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)

patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)

patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)

Outcomes

Primary Outcome Measures

Onset time of sensory block in 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).
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
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.
Duration of sensory block in hours
It's the time from sensory block onset to the time of restoration of sensation at the surgical site
Duration of motor block in hours
It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

Secondary Outcome Measures

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).
Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
Postoperative first analgesic request time in hours
was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
was given when VAS ≥ 4 cm
Mean blood pressure in mmHg
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
heart rate in beats / minute
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.
peripheral oxygen saturation
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.

Full Information

First Posted
December 1, 2020
Last Updated
December 12, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04666337
Brief Title
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine
Official Title
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Deformity of Elbow, Forearm, Hand, Wrist
Keywords
Supraclavicular Brachial Plexus Blockade, Fentanyl, Tramadol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Randomization established using the computer-generated closed envelopes method.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B (bupivacaine group)
Arm Type
Active Comparator
Arm Description
patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)
Arm Title
Group F (fentanyl group)
Arm Type
Active Comparator
Arm Description
patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)
Arm Title
Group T (tramadol group)
Arm Type
Active Comparator
Arm Description
patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided supraclavicular brachial plexus blockade
Intervention Description
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 Outcome Measure Information:
Title
Onset time of sensory block in minutes
Description
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).
Time Frame
40 minutes
Title
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
Description
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.
Time Frame
40 minutes
Title
Duration of sensory block in hours
Description
It's the time from sensory block onset to the time of restoration of sensation at the surgical site
Time Frame
24 hours
Title
Duration of motor block in hours
Description
It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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).
Description
Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
Time Frame
24 hours
Title
Postoperative first analgesic request time in hours
Description
was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.
Time Frame
24 hours
Title
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
Description
was given when VAS ≥ 4 cm
Time Frame
24 hours
Title
Mean blood pressure in mmHg
Description
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
Time Frame
24 hours
Title
heart rate in beats / minute
Description
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.
Time Frame
24 hours
Title
peripheral oxygen saturation
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
huda fahmy, ph D
Organizational Affiliation
Aswan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81511
Country
Egypt

12. IPD Sharing Statement

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Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

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