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Completed

NCT Number: NCT03767920

Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Bupivacaine

Drug

TAP block with 20 ml of 0.25% bupivacaine bilaterally

Other names: Active Comparator

Dexamethasone

Drug

TAP block with 4 mg dexamethasone bilaterally

Other names: active comparator

placebo to dexamethasone

Drug

TAP block with 4 mg placebo to dexamethasone bilaterally

Other names: Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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