Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

Not Applicable

Completed

• Conditions: Wrist; Forearm; Acquired Deformity of Elbow; Hand
• Interventions: Procedure: ultrasound-guided supraclavicular brachial plexus blockade

• Registration Number: NCT04666337
• Lead Sponsor: Aswan University Hospital

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)

Study Timeline

• Study Start: 2019-02-15
• Primary Completion: 2020-08-31
• Study Completion: 2020-09-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-12
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T (tramadol group)	ultrasound-guided supraclavicular brachial plexus blockade	patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)
Group F (fentanyl group)	ultrasound-guided supraclavicular brachial plexus blockade	patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)
Group B (bupivacaine group)	ultrasound-guided supraclavicular brachial plexus blockade	patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)

Primary Outcome Measures

Name	Time	Method
Onset time of sensory block in minutes	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).
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)	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.
Duration of sensory block in hours	24 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	24 hours	It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

Secondary Outcome Measures

Name	Time	Method
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously	24 hours	was given when VAS ≥ 4 cm
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	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	24 hours	was taken from the time of complete sensory block to the request to rescue analgesia when VAS \> 4 cm.
Mean blood pressure in mmHg	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
heart rate in beats / minute	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.
peripheral oxygen saturation	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.

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt