Condition or disease | Intervention/treatment | Phase |
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Upper Abdominal Surgery | Other: Subcostal Transversus Abdominis Plane catheter Other: Epidural catheter | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Double blind (participant, investigator) study |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries |
Actual Study Start Date : | May 10, 2019 |
Actual Primary Completion Date : | November 1, 2019 |
Actual Study Completion Date : | January 1, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Subcostal Transversus Abdominis Plane catheter
This group includes patients who will receive subcostal Transversus abdominis plane block analgesia
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Other: Subcostal Transversus Abdominis Plane catheter
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. |
Placebo Comparator: Epidural catheter
This group includes patients who will receive epidural analgesia using a catheter technique
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Other: Epidural catheter
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. |
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
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
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Egypt | |
Mansoura University | |
Mansoura, DK, Egypt, 050 |
Study Chair: | Mohamed Y Makharita, MD | Professor of Anesthesia and Surgical Intensive Care | |
Study Director: | Hazem ES Moawad, MD | Assistant Professor of Anesthesia and Surgical Intensive Care |
Tracking Information | |||||||||||
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First Submitted Date ICMJE | May 8, 2019 | ||||||||||
First Posted Date ICMJE | May 14, 2019 | ||||||||||
Last Update Posted Date | September 11, 2020 | ||||||||||
Actual Study Start Date ICMJE | May 10, 2019 | ||||||||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Total morphine consumption [ Time Frame: For 72 hours after surgery ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries | ||||||||||
Official Title ICMJE | Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries | ||||||||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double blind (participant, investigator) study Masking: Double (Participant, Investigator)Primary Purpose: Supportive Care |
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Condition ICMJE | Upper Abdominal Surgery | ||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Completed | ||||||||||
Actual Enrollment ICMJE |
84 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Actual Study Completion Date ICMJE | January 1, 2020 | ||||||||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||
Listed Location Countries ICMJE | Egypt | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT03949452 | ||||||||||
Other Study ID Numbers ICMJE | MD ∕ 17.12.104 | ||||||||||
Has Data Monitoring Committee | Yes | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mansoura University | ||||||||||
Study Sponsor ICMJE | Mansoura University | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | Mansoura University | ||||||||||
Verification Date | May 2019 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |