Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

NCT04666337 | Completed DMC

• 1 other identifier: 337/2/19
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Acquired Deformity of Elbow; Forearm; Hand; Wrist

Keywords

Supraclavicular Brachial Plexus Blockade; Fentanyl; Tramadol

Outcome Measures

Primary Outcomes (4)

• 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).

  40 minutes

• 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.

  40 minutes

• 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

  24 hours

• 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.

  24 hours

Secondary Outcomes (6)

• 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).

  24 hours

• Postoperative first analgesic request time in hours

  24 hours

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

  24 hours

• Mean blood pressure in mmHg

  24 hours

• heart rate in beats / minute

  24 hours

Study Arms (3)

Group B (bupivacaine group)

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Group F (fentanyl group)

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Group T (tramadol group)

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Interventions

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.

Group B (bupivacaine group); Group F (fentanyl group); Group T (tramadol group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81511, Egypt

Location

Study Officials

• huda fahmy, ph D

  Aswan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization established using the computer-generated closed envelopes method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 14, 2020
• Study Start: February 15, 2019
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

EG (1)