Ultrasound Guided Rectus Sheath BlockNCT03225313
Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair
A study testing Bupivacaine Hydrochloride 0.5% Injection Solution_#4 and Normal Saline Flush, 0.9% Injectable Solution_#5 in people with Ultrasound Guided Rectus Sheath Block and Pain, Postoperative, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Guided Rectus Sheath Block, Pain, Postoperative
- What is being tested?
- Bupivacaine Hydrochloride 0.5% Injection Solution_#4 and Normal Saline Flush, 0.9% Injectable Solution_#5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective midline hernia repair surgery.
- Age: adult patients between 18 - 60 years old.
- Gender: Both male and female.
- ASA Class: I \& II.
Who cannot join
- Refusal of patient.
- Pregnancy and lactation.
- Fever or sepsis.
- Patients ASA III or IV.
- Addicts and drug abusers.
- Patients taking corticosteroids or any cardio - active drugs.
- Local infection at site of the injection.
- Allergy to any of the study medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
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.
Read the 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.
- 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.
- 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.
- 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.
- Being tested
- Bupivacaine Hydrochloride 0.5% Injection Solution_#4, Normal Saline Flush, 0.9% Injectable Solution_#5
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 0.5% Injection Solution_#4Drug
ultra sound guided injection into the rectus sheath
Normal Saline Flush, 0.9% Injectable Solution_#5Drug
injected into rectus sheath using ultrasound \& locally surrounding the hernia
Bupivacaine Hydrochloride 0.5% Injection Solution_#4Drug
locally surrounding the hernia
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | normal saline will be injected in the rectus sheath Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution_#5 |
| Rectus block group | Active comparator | bupivicaine will be injected in the rectus sheath Receives: Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4 |
| Field block group | Experimental | bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia Receives: Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Evaluation of postoperative pain in patients at 6 hours after procedure.
Secondary outcomes (6)
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.
Measured: 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.
Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30 minutes before the start of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start10 Aug 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ultrasound Guided Rectus Sheath BlockStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hussein, Theodor Bilharz Research Institute
- Investigators
- mohammed ma hussein, lecturer, Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225313
- Sponsor's protocol ID
- 722014
- Status last verified
- Mar 2021
- First submitted
- 10 Jun 2017
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
- ClinicalTrials.gov ID
- NCT03225313
- Acronym / sponsor ID
- 722014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable Solution_#5normal saline will be injected in the rectus sheath |
| Rectus block group | Active comparator | Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4bupivicaine will be injected in the rectus sheath |
| Field block group | Experimental | Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective midline hernia repair surgery.
- Age: adult patients between 18 - 60 years old.
- Gender: Both male and female.
- ASA Class: I \& II.
Key exclusion criteria (8 listed)
- Refusal of patient.
- Pregnancy and lactation.
- Fever or sepsis.
- Patients ASA III or IV.
- Addicts and drug abusers.
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 |
|---|---|---|
| Bupivacaine Hydrochloride 0.5% Injection Solution_#4ultra sound guided injection into the rectus sheath | Drug | Rectus block group |
| Normal Saline Flush, 0.9% Injectable Solution_#5injected into rectus sheath using ultrasound \& locally surrounding the hernia | Drug | control group |
| Bupivacaine Hydrochloride 0.5% Injection Solution_#4locally surrounding the hernia | Drug | Field block group |
Primary outcome
Immediate Postoperative Pain
Time frame: 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.
Time frame: 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.
Time frame: 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.
6 secondary outcomes
Change in the Level of Serum Cortisol.
Time frame: 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.
Time frame: 1 hour after the start of the surgery using ELISA technique.
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Time frame: 1 hour after the start of the surgery
Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.
Time frame: 30 minutes before the start of the surgery
Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.
Time frame: 30 minutes before the start of the surgery
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Time frame: 30 minutes before the start of the surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
mohammed ma hussein, lecturer principal investigator
Theodor Bilharz Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine Hydrochloride 0.5% Injection Solution_#4 and Normal Saline Flush, 0.9% Injectable Solution_#5 in people with Ultrasound Guided Rectus Sheath Block and Pain, Postoperative, run by Theodor Bilharz Research Institute 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 4 inclusion and 8 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 9 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immediate Postoperative Pain (time frame: evaluation of postoperative pain in patients immediately after the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.