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

Analgesia Clinical Trial

— TAP_dexmedet  

Official title:

Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342844
• Other study ID #: TAP-dexmedetomidine
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 14, 2023

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 14, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Dexmedetomidine 0.5 mcg
0.5 mcg/kg
• Dexmedetomidine 1 mcg
1 mcg/kg

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of the first postoperative analgesic requirement		during the first 24 postoperative hours
Secondary	Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the	mg	during the first 24 postoperative hours
Secondary	The visual analog scale (VAS) scores during rest	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively	during the first 24 postoperative hours
Secondary	The visual analog scale (VAS) scores during movement	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively	during the first 24 postoperative hours
Secondary	Mean arterial blood pressure (MBP)	mmHg	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Secondary	heart rate (HR)	beat per minute	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Secondary	Patient satisfaction about the quality of postoperative analgesia	poor = 1, fair = 2, good = 3, excellent = 4	during the first 24 postoperative hours
Secondary	The side effects (nausea, vomiting, abdominal colic and lower limb weakness)	incidence	during the first 24 postoperative hours
Secondary	the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome		during the first 24 postoperative hours
Secondary	The level of sedation	using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)	during the first 24 postoperative hours