Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial

Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.

• Group 1: bupivacaine 0.25% + dexamethasone 8 mg
• Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: bupivacaine; Drug: dexamethasone; Drug: placebo to dexamethasone

Detailed Description

The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .

Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia

Exclusion Criteria:

• Participants had known sensitivity to bupivacaine
• patient refusal,
• localized infection over injection point
• patients with significant coagulopathies and
• with contraindications to regional anesthesia,
• patients with heart diseases, altered renal or liver functions,
• psychological disorders, patients with pregnancy-induced hypertension and
• gestational diabetes, chronic use of pain medications,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine and dexamethasone; Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.	Drug: bupivacaine; TAP block with 20 ml of 0.25% bupivacaine bilaterally; Other Names: Active Comparator; Drug: dexamethasone; TAP block with 4 mg dexamethasone bilaterally; Other Names: active comparator
Active Comparator: bupivacaine and placebo to dexamethasone; BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone	Drug: bupivacaine; TAP block with 20 ml of 0.25% bupivacaine bilaterally; Other Names: Active Comparator; Drug: placebo to dexamethasone; TAP block with 4 mg placebo to dexamethasone bilaterally; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog score for pain during movement	movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain	6 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days patients stay in hospital	calculation of number of days patients stay in hospital	4 weeks
Visual analog score during rest	ranging from 0 to 10, where 0 no pain and 10 maximum pain	48 hours postoperative
number of patients need Fentanyl consumption	number of patients need Fentanyl consumption	48 hours postoperative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cesarean section; transversus abdominis plane block; dexamethasone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: aswu/180/7/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No