Clinical Trials Directory

Trials / Completed

CompletedNCT03949452

Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.

Detailed description

Epidural analgesia, once considered the gold standard for major abdominal surgeries, but is often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Epidural analgesia is recently replaced by other techniques with an improved risk benefit ratio. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) approach is aimed to access the nerves in this neurofacial plane between internal oblique muscle and transversus abdominis through the lumbar triangle of Petit. Subcostal Transversus abdominis plane block, has been reported to provide analgesia for incisions extending above the umbilicus. However, there have been few clinical trials on the analgesic efficacy of continuous subcostal Transversus abdominis plane analgesia after major abdominal surgeries. It has been reported recently that supplemental magnesium has a role in providing perioperative analgesia, because this is a relatively harmless molecule, not expensive and because the biological basis for its potential antinociceptive effect is promising. No clinical studies have examined the effect of magnesium sulphate administered continuously in subcostal Transversus abdominis plane catheters as an adjunct to bupivacaine in postoperative analgesia. The aim of this study is to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia in major upper abdominal surgeries.

Conditions

Interventions

TypeNameDescription
OTHERSubcostal Transversus Abdominis Plane catheterPrior to surgery, an ultrasound guided unilateral Subcostal Transversus abdominis plane bolus dose (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) will be given on the same side of the surgical incision. At the end of surgery, A Transversus abdominis plane catheter will be inserted unilaterally by surgeon during wound closure. Then postoperatively, Transversus abdominis plane infusion of a solution mixture prepared in multiple 50 cm syringes each syringe contain 20 ml bupivacaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivacaine is 0.2%). This solution mixture will be infused through Transversus abdominis plane catheter at a rate of 6 ml/hour for 72 hours postoperatively.
OTHEREpidural catheterPrior to surgery, we will site an epidural catheter in the thoracic T7-T9 region, and inject an epidural bolus dose same as described above (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) for intra operative analgesia. Postoperatively, patients will receive epidural infusion of the solution mixture (same as described above) prepared in multiple 50 cm syringes each syringe contain 20 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivaccaine is 0.2%). This solution mixture will be infused epidurally at a rate of 6 ml/hour for 72 hours (3 days) postoperatively.

Timeline

Start date
2019-05-10
Primary completion
2019-11-01
Completion
2020-01-01
First posted
2019-05-14
Last updated
2020-09-11

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03949452. Inclusion in this directory is not an endorsement.