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The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcostal Transversus Abdominis Plane catheter | Active Comparator | This group includes patients who will receive subcostal Transversus abdominis plane block analgesia |
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| Epidural catheter | Placebo Comparator | This group includes patients who will receive epidural analgesia using a catheter technique |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcostal Transversus Abdominis Plane catheter | Other | Prior 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Intravenous morphine in adose of 0.05 mg/kg will be given if Visual Analogue Scale (VAS) is more than 30 mm in both groups and can be repeated every 15 minutes till Visual Analogue Scale become less than 3. Morphine administration will be ceased when the Visual Analogue Scale score <30 mm on assessment or when over-sedation or respiratory depression occurred (a respiratory rate of < 10 bpm). Doses given will be calculated daily and recorded. | For 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| First request for rescue analgesia | First time patient ask for analgesia: in the post anesthesia care unit (PACU) will be recorded and morphine in a dose of 0.05 mg/kg will be given and the time recorded. | for 72 hours after surgery |
| Pain Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Y Makharita, MD | Professor of Anesthesia and Surgical Intensive Care | Study Chair |
| Hazem ES Moawad, MD | Assistant Professor of Anesthesia and Surgical Intensive Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | DK | 050 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18227342 | Result | Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available. | |
| 11133627 | Result | Culebras X, Van Gessel E, Hoffmeyer P, Gamulin Z. Clonidine combined with a long acting local anesthetic does not prolong postoperative analgesia after brachial plexus block but does induce hemodynamic changes. Anesth Analg. 2001 Jan;92(1):199-204. doi: 10.1097/00000539-200101000-00038. |
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De-identified individual participant data for all primary and secondary outcome measures will be made available
data will be available within 6 monthes of study completion.
Data may be shared by contacting the principle investegator.
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Double blind (participant, investigator) study
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| Epidural catheter | Other | Prior 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. |
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| up to 72 hours postoperatively |
| Heart rate | Heart rate will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively. | for 72 hours postoperative |
| Mean arterial blood pressure | Mean arterial blood pressure will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively. | for 72 hours postoperative |
| Peripheral oxygen saturation | Peripheral oxygen saturation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively. | for 72 hours postoperative |
| Nausea and vomiting | Nausea and vomiting: will be assessed through nausea scores (none = 0, mild = 1, moderate = 2 and vomiting = 3) at 1, 2, 4, 8, 12, 24, 36, 48, 60,72 hrs post operativly. We offered rescue antiemetics to any patient who had a nausea score of 2 or more. | up to 72 hours postoperatively |
| Degree of sedation | Degree of sedation will be assessed by using the sedation scale described by Culebras (2001) as:
Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively | for 72 hours postoperative |
| Serum level of magnesium sulphate | Degree of sedation will be assessed by using the sedation scale described by Culebras (2001) as:
Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively | up to 72 hours postoperatively |
| Patient satisfaction with their analgesia |
| up to 72 hours postoperatively |
| Wound pain |
| up to 3 months postoperatively |