Upper Abdominal SurgeryNCT03949452
Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries
A study testing Subcostal Transversus Abdominis Plane catheter and Epidural catheter in people with Upper Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Abdominal Surgery
- What is being tested?
- Subcostal Transversus Abdominis Plane catheter and Epidural catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II or III
- The incision included is right subcostal incision for major upper abdominal surgeries (partial hepatectomy, pancreatic surgery included Whipple's procedure, total pancreatectomy and distal pancreatectomy) and other operations using the same incision.
Who cannot join
- Patient refusal.
- Hematological diseases.
- Bleeding diseases.
- Coagulation abnormality.
- Local skin infection
- Sepsis at site of the block.
Show all 10Show fewer
- Known hypersensitivity to the study drugs.
- Body Mass Index > 35 Kg/m2.
- If the lower end of the incision extended below T10 (umbilicus).
- If the incision extended laterally beyond the anterior axillary line or extended to pass the midline to the other side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries
The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.
Read the 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
- Upper Abdominal Surgery
- Being tested
- Subcostal Transversus Abdominis Plane catheter, Epidural catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane catheterOther
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.
Epidural catheterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subcostal Transversus Abdominis Plane catheter | Active comparator | This group includes patients who will receive subcostal Transversus abdominis plane block analgesia Receives: Other: Subcostal Transversus Abdominis Plane catheter |
| Epidural catheter | Placebo comparator | This group includes patients who will receive epidural analgesia using a catheter technique Receives: Other: Epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 72 hours after surgery
Secondary outcomes (10)
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.
Measured: for 72 hours after surgery
Pain Scores
- Presence and severity of pain will be assessed in All patients during rest and coughing using visual analogue scale (VAS).
- Visual analogue scale (VAS) ranging from 0 to 10 while 0 as no pain and 10 as worst imaginable pain.
- Presence and severity of pain will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 72 hours postoperatively
Degree of sedation
Degree of sedation will be assessed by using the sedation scale described by Culebras (2001) as:
- 1 : Awake and alert,
- 2 : Sedated, responding to verbal stimulus,
- 3 : Sedated, responding to mild physical stimulus,
- 4 : Sedated, responding only to moderate or severe physical stimulus
Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively
Measured: 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:
- 1 : Awake and alert,
- 2 : Sedated, responding to verbal stimulus,
- 3 : Sedated, responding to mild physical stimulus,
- 4 : Sedated, responding only to moderate or severe physical stimulus
Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively
Measured: up to 72 hours postoperatively
Patient satisfaction with their analgesia
- Patient satisfaction with their analgesia will be assessed as (poor = 1, fair = 2, good = 3, excellent = 4).
- Patient satisfaction with their analgesia will be assessed at 24, 48 and 72 hours post operatively.
Measured: up to 72 hours postoperatively
Wound pain
- Residual or chronic wound pain will be assessed in All patients using visual analogue scale (VAS).
- Visual analogue scale (VAS) ranging from 0 to 10 while 0 as no pain and 10 as worst imaginable pain.
- Residual wound pain will be assessed at 30, 60, 90 days postoperatively.
Measured: up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start10 May 2019
- Primary completion1 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind (participant, investigator) study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Y Makharita, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareHazem ES Moawad, MD, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949452
- Sponsor's protocol ID
- MD ∕ 17.12.104
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 18227342Culebras 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.
PubMed 11133627
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT03949452
- Acronym / sponsor ID
- MD ∕ 17.12.104
- Conditions
- Upper Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind (participant, investigator) study
| Arm | Type | Receives |
|---|---|---|
| Subcostal Transversus Abdominis Plane catheter | Active comparator | Other: Subcostal Transversus Abdominis Plane catheterThis group includes patients who will receive subcostal Transversus abdominis plane block analgesia |
| Epidural catheter | Placebo comparator | Other: Epidural catheterThis group includes patients who will receive epidural analgesia using a catheter technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I, II or III
- The incision included is right subcostal incision for major upper abdominal surgeries (partial hepatectomy, pancreatic surgery included Whipple's procedure, total pancreatectomy and distal pancreatectomy) and other operations using the same incision.
Key exclusion criteria (10 listed)
- Patient refusal.
- Hematological diseases.
- Bleeding diseases.
- Coagulation abnormality.
- Local skin infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcostal 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. | Other | Subcostal Transversus Abdominis Plane catheter |
| Epidural 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. | Other | Epidural catheter |
Primary outcome
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.
10 secondary outcomes
First request for rescue analgesia
Time frame: for 72 hours after surgery
Pain Scores
Time frame: up to 72 hours postoperatively
Heart rate
Time frame: for 72 hours postoperative
Mean arterial blood pressure
Time frame: for 72 hours postoperative
Peripheral oxygen saturation
Time frame: for 72 hours postoperative
Nausea and vomiting
Time frame: up to 72 hours postoperatively
Degree of sedation
Time frame: for 72 hours postoperative
Serum level of magnesium sulphate
Time frame: up to 72 hours postoperatively
Patient satisfaction with their analgesia
Time frame: up to 72 hours postoperatively
Wound pain
Time frame: up to 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Results publication: PubMed 18227342Hebbard 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.
- Results publication: PubMed 11133627Culebras 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Y Makharita, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Hazem ES Moawad, MD study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal Transversus Abdominis Plane catheter and Epidural catheter in people with Upper Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: For 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.