Completed

NCT Number: NCT04969705

Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.

Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period The transversus abdominus plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries

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Key information

Conditions

Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

ASA physical status classes I and II
Scheduled for elective cesarean section
Aged between 20-45 years .

Exclusion criteria

patient refusal.
patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease .
neuromuscular disorder.
infection.
bleeding disorder.
Obesity ( BMI > 30 kg/m2 ) .
History of allergy or sensitivity to any of the study drugs in previous surgeries .

Treatment and study plan

Dexmedetomidine

Drug

60 Patients will be randomly divided into three equal groups:

Group A (n=20) : spinal anesthesia with Dexmedetomidine (5µg ) added to local anesthetic (bupivacaine Hcl ) (10 mg) given intrathecally .

Group B (n=20) : spinal anesthesia using local anesthetic( bupivacaine Hcl) (20 mg) combined with TAP block using Dexmedetomidine (20µg ) after the cesarean section

Group C (n=20) (controlled group ) : Spinal anesthesia using only local anesthetic (bupivacaine Hcl ) (10 mg) .

Primary outcomes

Analgesic efficacy of both routes

Time frame: 24 hours

Demographic data (age, weight, and length), mean arterial blood pressure (MAP), and heart rate (HR) will be measured every 5 minutes intraoperatively and at 1, 2, 4, 6, 8,12,16,20 and 24 h postoperatively. Visual analog pain score (VAS) between 0 and 10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) will be recorded at 1, 2, 4, 6, 8,16,20 and 24 h postoperatively. First time of rescue analgesia: this is defined as the time from onset of sensory block till the time of first requirement of analgesia. The total amount of rescue analgesia consumption in the form of intravenous ketorolac→0.5 mg/kg if VAS greater than or equal to 4. Any undesirable postoperative side effects (as nausea, vomiting and pruritus) will be recorded and managed.

Secondary outcomes

1. Hemodynamic effect on the patient

Time frame: 1 hour

measuring BP , HR , oxygen saturation during operation every 5 minutes

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jul 21, 2021
Registry last updated: Jul 1, 2022

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.