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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03077581
Other study ID # D.Maha abdominoplasty
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 3, 2017
Last updated March 7, 2017
Start date March 1, 2017
Est. completion date June 15, 2017

Study information

Verified date March 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date June 15, 2017
Est. primary completion date June 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- all patients listed for abdominoplasty

Exclusion Criteria:

- allergy to bupivacaine

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Transevrsus abdominus plane block
a blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side.
Rectus sheath block
In RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side.
local anesthesia infiltartion
40 mls of 0.255 bupivacaine will be infiltrated at skin incision

Locations

Country Name City State
Egypt Mansoura university Mansoura Dakahleya

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphine consumption (mg) postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively up to 24 hours