Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Onset time of sensory block in minutes
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Randomization established using the computer-generated closed envelopes method.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Onset time of sensory block in minutes
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 24 hours
It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.
Secondary Outcomes
- 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)
- peripheral oxygen saturation(24 hours)
Investigators
huda fahmy
Assistant professor of Anesthesia and Intensive Care
Aswan University Hospital