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

• Sponsor: Mansoura University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05342844
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Dexmedetomidine 0.5 mcg; Drug: Dexmedetomidine 1 mcg	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 blockaccording 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
• Masking: Double (Participant, Investigator)
• Masking Description: The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
Active Comparator: 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	Drug: Dexmedetomidine 0.5 mcg; 0.5 mcg/kg
Active Comparator: 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	Drug: Dexmedetomidine 1 mcg; 1 mcg/kg

Outcome Measures

Primary Outcome Measures

1. The time of the first postoperative analgesic requirement [during the first 24 postoperative hours]

Secondary Outcome Measures

1. Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the [during the first 24 postoperative hours]

   mg

2. The visual analog scale (VAS) scores during rest [during the first 24 postoperative hours]

   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

3. The visual analog scale (VAS) scores during movement [during the first 24 postoperative hours]

   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

4. Mean arterial blood pressure (MBP) [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   mmHg

5. heart rate (HR) [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   beat per minute

6. Patient satisfaction about the quality of postoperative analgesia [during the first 24 postoperative hours]

   poor = 1, fair = 2, good = 3, excellent = 4

7. The side effects (nausea, vomiting, abdominal colic and lower limb weakness) [during the first 24 postoperative hours]

   incidence

8. the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome [during the first 24 postoperative hours]

9. The level of sedation [during the first 24 postoperative hours]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University-Emergency hospital-ICU	Mansoura		Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University
• ClinicalTrials.gov Identifier: NCT05342844
• Other Study ID Numbers: TAP-dexmedetomidine
• First Posted: Apr 25, 2022
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Jun 24, 2022