Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767920
• Other study ID #: aswu/180/7/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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,

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• bupivacaine
TAP block with 20 ml of 0.25% bupivacaine bilaterally
• dexamethasone
TAP block with 4 mg dexamethasone bilaterally
• placebo to dexamethasone
TAP block with 4 mg placebo to dexamethasone bilaterally

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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