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Comparison of Three Techniques for Analgesia After Abdominoplasty (Maha1)

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ClinicalTrials.gov Identifier: NCT03077581
Recruitment Status : Unknown
Verified March 2017 by AlRefaey Kandeel, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

Brief 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.

Condition or disease Intervention/treatment Phase
Abdominoplasty Patients Drug: Transevrsus abdominus plane block Drug: Rectus sheath block Drug: local anesthesia infiltartion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 5, 2017
Estimated Study Completion Date : June 15, 2017

Arm Intervention/treatment
Active Comparator: Transevrsus abdominus plane block group 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.

Active Comparator: Rectus sheath block group Drug: 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.

Active Comparator: local infiltration group Drug: local anesthesia infiltartion
40 mls of 0.255 bupivacaine will be infiltrated at skin incision




Primary Outcome Measures :
  1. morphine consumption (mg) [ Time Frame: up to 24 hours ]
    postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients listed for abdominoplasty

Exclusion Criteria:

  • allergy to bupivacaine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077581


Locations
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Egypt
Mansoura university
Mansoura, Dakahleya, Egypt
Sponsors and Collaborators
Mansoura University

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Responsible Party: AlRefaey Kandeel, lecturer, Mansoura University
ClinicalTrials.gov Identifier: NCT03077581     History of Changes
Other Study ID Numbers: D.Maha abdominoplasty
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No