Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries

NCT ID: NCT05323565

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-07-05

Brief Summary

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Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.

Detailed Description

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A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A (n=15): (Dexamethasone group)

Patients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

adjuvants to 0.25 bupivacaine in TAB block.

Group B (n=15): (Dexmedetomidine group)

Patients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

adjuvants to 0.25 bupivacaine in TAB block.

Group C (n=15): (control group)

Patients will receive 20 ml 0.25% bupivacaine on each side TAB block.

Group Type SHAM_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

adjuvants to 0.25 bupivacaine in TAB block.

Interventions

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Dexmedetomidine

adjuvants to 0.25 bupivacaine in TAB block.

Intervention Type DRUG

Other Intervention Names

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dexamethasone

Eligibility Criteria

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Inclusion Criteria

Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.

Exclusion Criteria

* Infection at site of injection.
* Patient refusal.
* Psychiatric or physical illness that lead to inability to cooperate, speak or read.
* Abdominal operations under spinal anesthesia.
* History or evidence of coagulopathy.
* Known allergies to drugs used .
* Preexisting neurological disorders.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Yasser Sayed Sobhy

Anesthesia specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser Sayed, Master

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University, Faculty of medecine

Locations

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Ain Shams University, Faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU M D 184/2020

Identifier Type: -

Identifier Source: org_study_id

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