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Randomized double blinded controlled clinical trial will be done with a total number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided rectus sheath block VS Field block infiltration in providing a good analgesia for patients undergoing midline hernia repair to detect which one is superior.
75 patients undergoing midline hernia repair under general anesthesia will be recruited and will be randomly allocated using closed envelope technique as follows: Control group, Local infilteration (Field block infilteration) group, Ultra sound Guided Rectus sheath block group.
General anesthesia will be standardized for all patients with :
2 µg kg-1 fentanyl and 2 mg kg-1 propofol. Neuromuscular blockade will be achieved with 0.5 mg kg-1 atracurium followed by tracheal intubation.
Muscle relaxation will be maintained by 0.1mg / kg / 30 minute of Atracrurium. Anesthesia will be maintained by sevoflurane. Mechanical ventilation will be adjusted with fresh gas flow oxygen in air 30-50% at a rate of 1 L min-1to maintain end-tidal carbon dioxide of 35-40 mm Hg and Spo2 greater than 94%.
BIS values will be maintained between 40 and 60. All surgical procedures will be done in the range between 10 am and 1 pm and by the same surgical team.
All solutions used will be prepared by a colleague who will not participate into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | normal saline will be injected in the rectus sheath |
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| Rectus block group | Active Comparator | bupivicaine will be injected in the rectus sheath |
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| Field block group | Experimental | bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride 0.5% Injection Solution_#4 | Drug | ultra sound guided injection into the rectus sheath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Postoperative Pain | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | evaluation of postoperative pain in patients immediately after the procedure. |
| Postoperative Pain at 2 Hours After Procedure. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | evaluation of postoperative pain in patients at 2 hours after procedure. |
| Postoperative Pain at 6 Hours After Procedure. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Evaluation of postoperative pain in patients at 6 hours after procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Level of Serum Cortisol. | Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery. | Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery. |
| Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mohammed ma hussein, lecturer | Theodor Bilharz Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theodor Bilharz Research Institute | Giza | Egypt |
Prospective randomized double blinded controlled clinical trial was done with a total number of 75 patients divided into 3 groups .
ASA I & II patients. 25 patient in each group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally |
| FG001 | Ultra- Sound Rectus Sheath Block Group | bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2017 |
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| Normal Saline Flush, 0.9% Injectable Solution_#5 | Drug | injected into rectus sheath using ultrasound & locally surrounding the hernia |
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| Bupivacaine Hydrochloride 0.5% Injection Solution_#4 | Drug | locally surrounding the hernia |
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Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. |
| 1 hour after the start of the surgery using ELISA technique. |
| Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. | 1 hour after the start of the surgery |
| Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. | Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery | 30 minutes before the start of the surgery |
| Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. | Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | 30 minutes before the start of the surgery |
| Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | 30 minutes before the start of the surgery. |
| FG002 | Local Infilteration Group | bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally |
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| NOT COMPLETED |
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count of participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally |
| BG001 | Ultra- Sound Rectus Sheath Block Group | bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath |
| BG002 | Local Infilteration Group | bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Weight in Kilograms | Mean | Standard Deviation | Kilogram |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immediate Postoperative Pain | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Posted | Mean | Standard Deviation | score on a scale | evaluation of postoperative pain in patients immediately after the procedure. |
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| Primary | Postoperative Pain at 2 Hours After Procedure. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Posted | Mean | Standard Deviation | score on a scale | evaluation of postoperative pain in patients at 2 hours after procedure. |
| |||||||||||||||||||||||||||||||||
| Primary | Postoperative Pain at 6 Hours After Procedure. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved. | Posted | Mean | Standard Deviation | score on a scale | Evaluation of postoperative pain in patients at 6 hours after procedure. |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in the Level of Serum Cortisol. | Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery. | Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery. | Posted | Mean | Standard Deviation | nmol/ liter | Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. | Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. | Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. | Posted | Mean | Standard Deviation | ng/ml | 1 hour after the start of the surgery using ELISA technique. |
|
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| Secondary | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. | Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. | Posted | Mean | Standard Deviation | ng/ml | 1 hour after the start of the surgery |
|
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| Secondary | Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. | Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery | Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery | Posted | Mean | Standard Deviation | nmol/ liter | 30 minutes before the start of the surgery |
|
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| Secondary | Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. | Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | Posted | Mean | Standard Deviation | ng/ml | 30 minutes before the start of the surgery |
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| Secondary | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | Measurement of serum noradreline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery. | Posted | Mean | Standard Deviation | ng/ml | 30 minutes before the start of the surgery. |
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24 hours after giving the local anaesthesia
Cardiac arrhythmia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Ultra- Sound Rectus Sheath Block Group | bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Local Infilteration Group | bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Muhammed Hussein | Theodor Bilharz Research Institute | 00201001434459 | muhamed.hussein@gmail.com |
| Mar 6, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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