Fentanyl Versus Tramadol as Co-administrator to Bupivacaine

NCT ID: NCT04666337

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-09-30

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)

Conditions

Acquired Deformity of Elbow; Forearm; Hand; Wrist

Keywords

Supraclavicular Brachial Plexus Blockade; Fentanyl; Tramadol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group B (bupivacaine group)

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

Group Type: ACTIVE_COMPARATOR

ultrasound-guided supraclavicular brachial plexus blockade

Intervention Type: 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 F (fentanyl group)

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

Group Type: ACTIVE_COMPARATOR

ultrasound-guided supraclavicular brachial plexus blockade

Intervention Type: 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 T (tramadol group)

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

Group Type: ACTIVE_COMPARATOR

ultrasound-guided supraclavicular brachial plexus blockade

Intervention Type: 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.

Interventions

ultrasound-guided supraclavicular brachial plexus blockade

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

huda fahmy

Assistant professor of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

huda fahmy, ph D

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Other Identifiers

337/2/19

Identifier Type: -

Identifier Source: org_study_id