Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

• ClinicalTrials.gov Identifier: NCT03767920
• Recruitment Status: Completed
• First Posted: December 7, 2018
• Last Update Posted: August 5, 2020
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): hany farouk, Aswan University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cesarean Section	Drug: bupivacaine; Drug: dexamethasone; Drug: placebo to dexamethasone	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective Randomized Interventional double-blind study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
• Primary Purpose: Prevention
• Official Title: Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: March 30, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

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 Name: Active Comparator; Drug: dexamethasone; TAP block with 4 mg dexamethasone bilaterally; Other Name: 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 Name: Active Comparator; Drug: placebo to dexamethasone; TAP block with 4 mg placebo to dexamethasone bilaterally; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Visual analog score for pain during movement [ Time Frame: 6 hours post operative ]
   movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary Outcome Measures :

1. Visual analog score during rest [ Time Frame: 48 hours postoperative ]
   ranging from 0 to 10, where 0 no pain and 10 maximum pain
2. number of patients need Fentanyl consumption [ Time Frame: 48 hours postoperative ]
   number of patients need Fentanyl consumption
3. number of days patients stay in hospital [ Time Frame: 4 weeks ]
   calculation of number of days patients stay in hospital

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: healthy parturient scheduled to undergo LSCS under spinal anesthesia
• Accepts Healthy Volunteers: No

Criteria

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,

Contacts and Locations

Locations

Egypt

Aswan University

Aswan, Egypt, 81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

• Principal Investigator: hany f sallam, md; Aswan University Hospital

More Information

• Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT03767920
• Other Study ID Numbers: aswu/180/7/18
• First Posted: December 7, 2018
• Last Update Posted: August 5, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:

dexamethasone; transversus abdominis plane block; cesarean section

Additional relevant MeSH terms:

Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents