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

NCT05342844 | Completed

• 1 other identifier: TAP-dexmedetomidine
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The time of the first postoperative analgesic requirement

  during the first 24 postoperative hours

Secondary Outcomes (9)

• Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the

  during the first 24 postoperative hours

• The visual analog scale (VAS) scores during rest

  during the first 24 postoperative hours

• The visual analog scale (VAS) scores during movement

  during the first 24 postoperative hours

• Mean arterial blood pressure (MBP)

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

• heart rate (HR)

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

Study Arms (3)

Group-Control

NO INTERVENTION

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-Dexmedetomidine 0.5

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine 0.5 mcg

Group-Dexmedetomidine1

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine 1 mcg

Interventions

Dexmedetomidine 0.5 mcg DRUG

0.5 mcg/kg

Group-Dexmedetomidine 0.5

Dexmedetomidine 1 mcg DRUG

1 mcg/kg

Group-Dexmedetomidine1

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: singleton pregnant women with a gestational age of at least 37 weeks
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: 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

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 25, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 14, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

EG (1)