Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

NCT ID: NCT05342844

Last Updated: 2023-06-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-06-14

Brief Summary

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Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties

Detailed Description

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This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection

Study Groups

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Group-Control

After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side

Group Type NO_INTERVENTION

No interventions assigned to this group

Group-Dexmedetomidine 0.5

After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 0.5 mcg

Intervention Type DRUG

0.5 mcg/kg

Group-Dexmedetomidine1

After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 1 mcg

Intervention Type DRUG

1 mcg/kg

Interventions

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Dexmedetomidine 0.5 mcg

0.5 mcg/kg

Intervention Type DRUG

Dexmedetomidine 1 mcg

1 mcg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age from 19 to 40 years old
* American Society of Anesthesiologists (ASA) physical status II patients
* Singleton pregnancies with a gestational age of at least 37 weeks.
* Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria

* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* Inability to comprehend or participate in the pain scoring system.
* Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Hypersensitivity to any drug used in the study.
* Any hypertensive disorders of pregnancy.
* Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
* Significant cardiovascular, renal or hepatic abnormalities.
* Patients with history of opioid intake, drug abusers or psychiatric patients
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University-Emergency hospital-ICU

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TAP-dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id

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