Clincosm LogoSign in Get a demo

Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04551833
Collaborator
(none)
60
Enrollment
2
Arms
25
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures.

Primary outcome: duration of postoperative analgesia. Secondary outcome: include [The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone .

Dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres .

Tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group (T) : 30 patients (Tramadol group)

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.

Drug: Levobupivacaine
Tramadol versus Dexamethasone as adjuvant to Levobupvacain
Experimental: Group (D) : 30 patients (Dexamethasone group):

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone

Drug: Levobupivacaine
Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Outcome Measures

Primary Outcome Measures

  1. Duration of postoperative analgesia in hours [24 hours]

    Duration of postoperative analgesia in hours

Secondary Outcome Measures

  1. The anesthesia onset time [20 minutes]

    Anasthesia onset

  2. Dose of Paracetamol as rescue analgesia in mg [24 hours]

    Rescue Analgesia in mg

  3. Presence of complications and side effects [24 hours]

    complications and side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures

  • Both sexes

Exclusion Criteria:

  • Patients with known allergy to the study drugs

  • Skin infection at site of needle puncture

  • Significant organ dysfunction

  • Coagulopathy

  • Drug or alcohol abuse

  • Epilepsy and psychiatric illness that would interfere with perception and assessment of pain

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Esraa Gamal, Resident of Anesthesia, ICU and Pain management, Assiut University
ClinicalTrials.gov Identifier:
NCT04551833
Other Study ID Numbers:
  • supraclavicular block
First Posted:
Sep 16, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Levobupivacaine

Study Results

No Results Posted as of Sep 16, 2020