Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective Randomized Interventional double-blind study.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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bupivacaine and dexamethasone

Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

TAP block with 20 ml of 0.25% bupivacaine bilaterally

dexamethasone

Intervention Type DRUG

TAP block with 4 mg dexamethasone bilaterally

bupivacaine and placebo to dexamethasone

BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

TAP block with 20 ml of 0.25% bupivacaine bilaterally

placebo to dexamethasone

Intervention Type DRUG

TAP block with 4 mg placebo to dexamethasone bilaterally

Interventions

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bupivacaine

TAP block with 20 ml of 0.25% bupivacaine bilaterally

Intervention Type DRUG

dexamethasone

TAP block with 4 mg dexamethasone bilaterally

Intervention Type DRUG

placebo to dexamethasone

TAP block with 4 mg placebo to dexamethasone bilaterally

Intervention Type DRUG

Other Intervention Names

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Active Comparator active comparator Placebo

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No