Pain, Postoperative, Ultrasound Guided Rectus Sheath Block
Conditions
Brief summary
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.
Detailed description
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. 1. Control group : will receive field block using 0.3 ml/kg of normal saline at site of the hernia plus ultra- sound guided rectus sheath injection using 0.3 ml / kg of normal saline. 2. Field block group: will receive 0.3 ml / kg of 0.5% bupivicaine subcutaneously surrounding the site of the hernia following the induction of anesthesia and ultra-sound guided rectus sheath block with 0.3 ml / kg of normal saline. 3. Ultrasound guided rectus sheath block : Under sterile conditions a 21/22 G , 50- 100 milli meter length echogenic needle guided by the ultrasound into rectus sheath at the level of the umbilicus , using an - in plane technique. After -ve aspiration 0.3 ml/ kg of 0.5 % bupivicaine will be deposited on each side and the spread of local anesthesia will be observed by ultrasound plus 0.3 ml/kg of normal saline subcutaneously at the site of the hernia. All solutions used will be prepared by a colleague who will not participate into the study.
Interventions
DRUGBupivacaine Hydrochloride 0.5% Injection Solution_#4
ultra sound guided injection into the rectus sheath
DRUGNormal Saline Flush, 0.9% Injectable Solution_#5
injected into rectus sheath using ultrasound & locally surrounding the hernia
Sponsors
Theodor Bilharz Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Elective midline hernia repair surgery. 2. Age: adult patients between 18 - 60 years old. 3. Gender: Both male and female. 4. ASA Class: I & II.
Exclusion criteria
1. Refusal of patient. 2. Pregnancy and lactation. 3. Fever or sepsis. 4. Patients ASA III or IV. 5. Addicts and drug abusers. 6. Patients taking corticosteroids or any cardio - active drugs. 7. Local infection at site of the injection. 8. Allergy to any of the study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Postoperative Pain | evaluation of postoperative pain in patients immediately after the 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. |
| Postoperative Pain at 2 Hours After Procedure. | evaluation of postoperative pain in patients 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. |
| Postoperative Pain at 6 Hours After Procedure. | Evaluation of postoperative pain in patients 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
| Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. | 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. |
| Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 1 hour after the start of the surgery | Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique. |
Countries
Egypt
Participant flow
Recruitment details
ASA I & II patients. 25 patient in each group.
Pre-assignment details
Prospective randomized double blinded controlled clinical trial was done with a total number of 75 patients divided into 3 groups .
Participants by arm
| Arm | Count |
|---|---|
| Control Group normal saline will be injected in the rectus sheath
Normal saline: injected into rectus sheath & locally | 25 |
| Ultra- Sound Rectus Sheath Block Group bupivicaine will be injected in the rectus sheath
Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath | 25 |
| Local Infilteration Group bupivicaine will be injected locally
Bupivacaine Hydrochloride: injected locally | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Control Group | Ultra- Sound Rectus Sheath Block Group | Local Infilteration Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 25 Participants | 75 Participants |
| Age, Continuous | 44.80 years STANDARD_DEVIATION 9.941 | 42.20 years STANDARD_DEVIATION 10.464 | 44.08 years STANDARD_DEVIATION 8.544 | 43.76 years STANDARD_DEVIATION 9.606 |
| Body Weight in Kilograms | 82.7 Kilogram STANDARD_DEVIATION 13.9 | 83.7 Kilogram STANDARD_DEVIATION 11.8 | 82 Kilogram STANDARD_DEVIATION 10.6 | 82.87 Kilogram STANDARD_DEVIATION 12.115 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Egypt | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 22 Participants | 17 Participants | 19 Participants | 58 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: evaluation of postoperative pain in patients immediately after the procedure.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Immediate Postoperative Pain | 7.36 score on a scale | Standard Deviation 2.691 |
| Ultra- Sound Rectus Sheath Block Group | Immediate Postoperative Pain | 1.04 score on a scale | Standard Deviation 1.837 |
| Local Infilteration Group | Immediate Postoperative Pain | 6.56 score on a scale | Standard Deviation 3.029 |
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.
Time frame: evaluation of postoperative pain in patients at 2 hours after procedure.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Postoperative Pain at 2 Hours After Procedure. | 6.04 score on a scale | Standard Deviation 1.645 |
| Ultra- Sound Rectus Sheath Block Group | Postoperative Pain at 2 Hours After Procedure. | 1.20 score on a scale | Standard Deviation 1.826 |
| Local Infilteration Group | Postoperative Pain at 2 Hours After Procedure. | 5.12 score on a scale | Standard Deviation 1.833 |
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.
Time frame: Evaluation of postoperative pain in patients at 6 hours after procedure.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Postoperative Pain at 6 Hours After Procedure. | 5.28 score on a scale | Standard Deviation 2.011 |
| Ultra- Sound Rectus Sheath Block Group | Postoperative Pain at 6 Hours After Procedure. | 2.64 score on a scale | Standard Deviation 1.497 |
| Local Infilteration Group | Postoperative Pain at 6 Hours After Procedure. | 5.16 score on a scale | Standard Deviation 2.304 |
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.
Time frame: Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
Population: Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in the Level of Serum Cortisol. | 307.84 nmol/ liter | Standard Deviation 220.569 |
| Ultra- Sound Rectus Sheath Block Group | Change in the Level of Serum Cortisol. | 214.00 nmol/ liter | Standard Deviation 148.198 |
| Local Infilteration Group | Change in the Level of Serum Cortisol. | 286.92 nmol/ liter | Standard Deviation 225.404 |
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.
Time frame: 30 minutes before the start of the surgery
Population: Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. | 1.42 ng/ml | Standard Deviation 0.774 |
| Ultra- Sound Rectus Sheath Block Group | Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. | 3.96 ng/ml | Standard Deviation 2.262 |
| Local Infilteration Group | Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. | 2.00 ng/ml | Standard Deviation 1.416 |
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.
Time frame: 1 hour after the start of the surgery using ELISA technique.
Population: Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. | 2.508 ng/ml | Standard Deviation 1.253 |
| Ultra- Sound Rectus Sheath Block Group | Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. | 2.556 ng/ml | Standard Deviation 1.403 |
| Local Infilteration Group | Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. | 2.704 ng/ml | Standard Deviation 1.1264 |
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
Time frame: 30 minutes before the start of the surgery
Population: Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. | 159.02 nmol/ liter | Standard Deviation 119.455 |
| Ultra- Sound Rectus Sheath Block Group | Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. | 327.05 nmol/ liter | Standard Deviation 215.569 |
| Local Infilteration Group | Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. | 170.52 nmol/ liter | Standard Deviation 91.421 |
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.
Time frame: 1 hour after the start of the surgery
Population: Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 12.088 ng/ml | Standard Deviation 4.6656 |
| Ultra- Sound Rectus Sheath Block Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 17.380 ng/ml | Standard Deviation 9.0959 |
| Local Infilteration Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 15.920 ng/ml | Standard Deviation 7.3389 |
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.
Time frame: 30 minutes before the start of the surgery.
Population: Measurement of serum noradreline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 9.960 ng/ml | Standard Deviation 4.288 |
| Ultra- Sound Rectus Sheath Block Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 20.880 ng/ml | Standard Deviation 10.5235 |
| Local Infilteration Group | Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. | 12.932 ng/ml | Standard Deviation 6.4223 |