Clinical trial NCT04666337: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Deformity of Elbow
Forearm
Hand
Wrist
Keywords: Supraclavicular Brachial Plexus Blockade
Fentanyl
Tramadol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Onset time of sensory block in minutes
timeFrame: 40 minutes
measure: onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
timeFrame: 40 minutes
measure: Duration of sensory block in hours
timeFrame: 24 hours
measure: Duration of motor block in hours
timeFrame: 24 hours
Secondary outcomes:
measure: 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).
timeFrame: 24 hours
measure: Postoperative first analgesic request time in hours
timeFrame: 24 hours
measure: Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
timeFrame: 24 hours
measure: Mean blood pressure in mmHg
timeFrame: 24 hours
measure: heart rate in beats / minute
timeFrame: 24 hours
measure: peripheral oxygen saturation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University
name: huda fahmy, ph D
role: PRINCIPAL_INVESTIGATOR
References: