Comparison of Three Techniques for Analgesia After Abdominoplasty

NCT ID: NCT03077581

Last Updated: 2017-03-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominoplasty Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transevrsus abdominus plane block group

Group Type ACTIVE_COMPARATOR

Transevrsus abdominus plane block

Intervention Type DRUG

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 group

Group Type ACTIVE_COMPARATOR

Rectus sheath block

Intervention Type DRUG

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 infiltration group

Group Type ACTIVE_COMPARATOR

local anesthesia infiltartion

Intervention Type DRUG

40 mls of 0.255 bupivacaine will be infiltrated at skin incision

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

local anesthesia infiltartion

40 mls of 0.255 bupivacaine will be infiltrated at skin incision

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients listed for abdominoplasty

Exclusion Criteria

* allergy to bupivacaine
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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D.Maha abdominoplasty

Identifier Type: -

Identifier Source: org_study_id

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