Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

Aswan University Hospital

Status: Completed

Conditions: Wrist; Forearm; Acquired Deformity of Elbow; Hand

Treatments: Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT04666337

337/2/19

Details and patient eligibility

About

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

Full 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)

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

Group B (bupivacaine group)

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Group F (fentanyl group)

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound-guided supraclavicular brachial plexus blockade

Group T (tramadol group)

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound-guided supraclavicular brachial plexus blockade