Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05447455
Other study ID # AN2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date January 31, 2022

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 31, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: 1. Women who underwent cesarean section under spinal anesthesia. 2. Aged =19 years and less than 40 years. 3. Gestational age = 37 Weeks. Exclusion Criteria: 1. Body mass index (BMI) =40 kg/m2. 2. History of recent opioid exposure 3. Hypersensitivity to any of the drugs used in the study. 4. Significant cardiovascular, renal, or hepatic disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transversus Abdominis Plane Block
A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.
Local anesthetic wound infiltration
40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure

Locations

Country Name City State
Egypt faculty of medicine - Cairo university Cairo Kasr El Ainy

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively , using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain). 24 hours
Secondary measures the time to the first postoperative opioid dose 24 hours
Secondary cumulative opioid consumption at 2, 4, 6, and 12 hours. 12 hours
See also
  Status Clinical Trial Phase
Completed NCT04037085 - Ketamine to Improve Recovery After Cesarean Delivery - Part 1 Phase 2
Recruiting NCT03623256 - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia Phase 4
Completed NCT04443569 - Lidocaine Patches After Cesarean Section Phase 3
Completed NCT03502642 - Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery Phase 4
Completed NCT03596333 - Color Doppler Ultrasound to Locate Needle in Labor Epidural
Recruiting NCT02427139 - ANSiStim Study for Active Labor Pain N/A
Not yet recruiting NCT06304246 - The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section
Completed NCT06429111 - Effectiveness and Safety in Maternal and Neonatal Outcomes in Water Birth.
Not yet recruiting NCT05196256 - Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia. Phase 3
Not yet recruiting NCT04983511 - Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population N/A
Completed NCT02244086 - Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor Phase 4
Completed NCT03495531 - Virtual Reality in Obstetric Patients N/A
Completed NCT00361712 - Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production Phase 4
Completed NCT03634111 - The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section N/A
Terminated NCT04011098 - Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour Phase 1
Not yet recruiting NCT06055686 - The Use of Electrical Stimulation for Determination of Epidural Catheter Placement N/A
Withdrawn NCT02857465 - Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome Phase 3
Completed NCT02340806 - Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses N/A
Recruiting NCT04728048 - Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia N/A
Completed NCT04637386 - TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT N/A