Postoperative PainTAPblockNCT04223128
Comparing Intravenous Magnesium Sulfate With Dexamethasone as Adjuvants to Ultrasound Guided TAPblock
A study testing Ultrasound guided transversus abdominis plane block in people with Postoperative Pain, run by Tamer Nabil Abdelrahman at 1 site in Egypt.
Trial summary
TAP block provided increased postoperative analgesia and reduced analgesic requirements as part of a multimodal analgesic regimen. The aim of the study is to compare the efficacy of single low dose of intravenous MgSO4 versus intravenous dexamethasone as adjuvants to ultrasound guided TAP block for prolongation of… Read more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound guided transversus abdominis plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 3 Apr 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 Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- singleton full term pregnancy ( completed 37 weeks)
- undergoing elective cesarean section
- ASA I, II
Who cannot join
- patients with ASA physical status class III-IV,
- morbid obesity with BMI > 35 kg.m-2 at initial hospital visit
- neuro-axial anaesthesia
- severe pre-eclampsia,
- diabetes mellitus,
- cardiovascular disease,
Show all 14Show fewer
- renal disease,
- hypermagnesemia,
- history of analgesic administration or intake during past 24 hours,
- chronic use of steroids therapy,
- urgent cesarean sections,
- multiple gestations,
- history of relevant drug allergy,
- any possibility of anticipated difficult intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Intravenous Single Low Doses of Magnesium Sulphate Versus Dexamethasone as Adjuvants to Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Prolongation of Postcesaren Analgesia
TAP block provided increased postoperative analgesia and reduced analgesic requirements as part of a multimodal analgesic regimen.
The aim of the study is to compare the efficacy of single low dose of intravenous MgSO4 versus intravenous dexamethasone as adjuvants to ultrasound guided TAP block for prolongation of postcesaren analgesia
Read the detailed description
Study Setting: Ain shams University maternity Hospitals, Cairo, Egypt. Study Period: 4 months from 1st December 2019 to 1st April 2020. Sampling Method: Random sample Sample Size: 60 patients Study Design A total of (60) full term pregnant women (completed 37 weeks) will be recruited for the study will undergo elective cesarean section. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (20) Patients each. The first group patients will be assigned to magnesium sulphate group (M), the second group of patients will be assigned to dexamethasone group (D) and the third group will be assigned to placebo group (C). Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study. Blind grouping will be kept to all including the patients themselves, until the completion of study.
Preoperative Anesthetic Assessment All patients will be subjected to a thorough medical history, physical examination with thorough airway assessment, laboratory investigations (fasting blood sugar, kidney, liver function tests, serum electrolytes, coagulation profile, and electrocardiogram) preoperatively. They will be also counseled about the anesthetic management and potential complications of both surgery and anesthesia, and the explanations of numerical pain analogue scale (NAS) from 0-10. All these data will be documented.
Anesthetic Protocol All participants will be admitted to operating theatre (OR) induction area where patient identification is confirmed and an 18-gauge intravenous cannula will be inserted to all Participants. Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes, participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV while participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control.
General anesthesia will be induced with intravenous propofol 2.0 mg/kg, succinyl choline 1.0 mg/Kg then they will be intubated orally which is fixed after confirmation of its place by capnography and auscultation. Anesthesia will be maintained by 2% sevoflurane in 100% oxygen then atracurium 0.1 mg/kg will be given for maintenance of muscle relaxation. After delivery of the fetus and placenta, 2 mg midazolam, 1 µg/kg fentanyl and 10 IU oxytocin (in 500 ml ringer solution) will be administrated. Immediately after completion of surgery, each patient will receive ultrasound guided bilateral ultrasound guided TAP blocks. After that muscle relaxant will be antagonized by 40 µg/kg neostigmine and 20 µg/kg atropine, then awake extubation will be done and the patients will be transferred to the recovery unit. All patients will be monitored all through the surgery by standard monitors including, electrocardiogram, the pulse oximeter, non-invasive blood pressure, and capnography.
TAP Block Technique Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist.
Postoperative Analgesic Regimen It will start immediately on arrival to the recovery unit where all patients will receive 1 gm of Acetaminophen IV. After that all patients will continue on acetaminophen 1 gm/6 h IV and 5 mg Nalbuphine IV will be given if breakthrough pain develops during the first day postoperative.
Patients Assessment Patients will be transferred to Post-anesthesia care unit PACU and upon arrival to PACU, a pulse oximeter and Non-invasive blood pressure (NIBP) monitors will be attached to the patients. Discharge criteria from PACU will be stable vital signs, pain score less than or equal to 2, no nausea or vomiting, calm and alert patient.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound guided transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided transversus abdominis plane blockProcedure or surgery
Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate group(M) | Active comparator | Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes then ultrasound guided TAPblock after closure of the abdomen Receives: Procedure: Ultrasound guided transversus abdominis plane block |
| Dexamethasone group(D) | Active comparator | participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV then ultrasound guided TAPblock after closure of the abdomen Receives: Procedure: Ultrasound guided transversus abdominis plane block |
| Placebo group(C) | Placebo comparator | participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control then ultrasound guided TAPblock after closure of the abdomen Receives: Procedure: Ultrasound guided transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of postoperative analgesia
pain assessed by visual analogue scale from 0- 10 as 0 means no pain and 10 worst pain and 0-3 mild pain , 4-7 moderate pain and 7-10 severe pain
Measured: the first 24 hours postoperative
The duration of analgesia before needing rescue analgesia
Time in minutes
Measured: First 24 hours postoperative
Frequency of rescue analgesia needed
Measured: First 24 hours postoperative
Secondary outcomes (4)
fetal safety
assessed by APGAR score from 1- 10 the higher the score the better the baby health a score of 7 to 9 means normal newborn and is a sign of good health after birth
Measured: first minute and at 5 minutes postdelivery
time needed to ambulate unaided
Measured in hours
Measured: the first 24 hours postoperatively
patient hemodynamics
heart rate (BPM)
Measured: Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery
Patient hemodynamics
Mean arterial blood pressure(mmHg)
Measured: Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Dec 2019
- Primary completion1 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Group M and group D are parallel and compared to group C
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamer Nabil Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamer Nabil Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223128
- Sponsor's protocol ID
- FAMSU R 59/2019
- Acronym
- TAPblock
- Status last verified
- Aug 2020
- First submitted
- 4 Jan 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intravenous Single Low Doses of Magnesium Sulphate Versus Dexamethasone as Adjuvants to Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Prolongation of Postcesaren Analgesia
- ClinicalTrials.gov ID
- NCT04223128
- Acronym / sponsor ID
- TAPblock / FAMSU R 59/2019
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tamer Nabil AbdelrahmanUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 10 Jan 2020 (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.
TAP block provided increased postoperative analgesia and reduced analgesic requirements as part of a multimodal analgesic regimen.
The aim of the study is to compare the efficacy of single low dose of intravenous MgSO4 versus intravenous dexamethasone as adjuvants to ultrasound guided TAP block for prolongation of postcesaren analgesia
Detailed description
Study Setting: Ain shams University maternity Hospitals, Cairo, Egypt. Study Period: 4 months from 1st December 2019 to 1st April 2020. Sampling Method: Random sample Sample Size: 60 patients Study Design A total of (60) full term pregnant women (completed 37 weeks) will be recruited for the study will undergo elective cesarean section. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (20) Patients each. The first group patients will be assigned to magnesium sulphate group (M), the second group of patients will be assigned to dexamethasone group (D) and the third group will be assigned to placebo group (C). Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study. Blind grouping will be kept to all including the patients themselves, until the completion of study.
Preoperative Anesthetic Assessment All patients will be subjected to a thorough medical history, physical examination with thorough airway assessment, laboratory investigations (fasting blood sugar, kidney, liver function tests, serum electrolytes, coagulation profile, and electrocardiogram) preoperatively. They will be also counseled about the anesthetic management and potential complications of both surgery and anesthesia, and the explanations of numerical pain analogue scale (NAS) from 0-10. All these data will be documented.
Anesthetic Protocol All participants will be admitted to operating theatre (OR) induction area where patient identification is confirmed and an 18-gauge intravenous cannula will be inserted to all Participants. Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes, participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV while participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control.
General anesthesia will be induced with intravenous propofol 2.0 mg/kg, succinyl choline 1.0 mg/Kg then they will be intubated orally which is fixed after confirmation of its place by capnography and auscultation. Anesthesia will be maintained by 2% sevoflurane in 100% oxygen then atracurium 0.1 mg/kg will be given for maintenance of muscle relaxation. After delivery of the fetus and placenta, 2 mg midazolam, 1 µg/kg fentanyl and 10 IU oxytocin (in 500 ml ringer solution) will be administrated. Immediately after completion of surgery, each patient will receive ultrasound guided bilateral ultrasound guided TAP blocks. After that muscle relaxant will be antagonized by 40 µg/kg neostigmine and 20 µg/kg atropine, then awake extubation will be done and the patients will be transferred to the recovery unit. All patients will be monitored all through the surgery by standard monitors including, electrocardiogram, the pulse oximeter, non-invasive blood pressure, and capnography.
TAP Block Technique Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist.
Postoperative Analgesic Regimen It will start immediately on arrival to the recovery unit where all patients will receive 1 gm of Acetaminophen IV. After that all patients will continue on acetaminophen 1 gm/6 h IV and 5 mg Nalbuphine IV will be given if breakthrough pain develops during the first day postoperative.
Patients Assessment Patients will be transferred to Post-anesthesia care unit PACU and upon arrival to PACU, a pulse oximeter and Non-invasive blood pressure (NIBP) monitors will be attached to the patients. Discharge criteria from PACU will be stable vital signs, pain score less than or equal to 2, no nausea or vomiting, calm and alert patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Group M and group D are parallel and compared to group C
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate group(M) | Active comparator | Procedure: Ultrasound guided transversus abdominis plane blockParticipants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes then ultrasound guided TAPblock after closure of the abdomen |
| Dexamethasone group(D) | Active comparator | Procedure: Ultrasound guided transversus abdominis plane blockparticipants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV then ultrasound guided TAPblock after closure of the abdomen |
| Placebo group(C) | Placebo comparator | Procedure: Ultrasound guided transversus abdominis plane blockparticipants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control then ultrasound guided TAPblock after closure of the abdomen |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- singleton full term pregnancy ( completed 37 weeks)
- undergoing elective cesarean section
- ASA I, II
Key exclusion criteria (14 listed)
- patients with ASA physical status class III-IV,
- morbid obesity with BMI > 35 kg.m-2 at initial hospital visit
- neuro-axial anaesthesia
- severe pre-eclampsia,
- diabetes mellitus,
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 |
|---|---|---|
| Ultrasound guided transversus abdominis plane blockUsing an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist. | Procedure or surgery | Dexamethasone group(D), Magnesium sulfate group(M), Placebo group(C) |
Primary outcome
Efficacy of postoperative analgesia
Time frame: the first 24 hours postoperative
pain assessed by visual analogue scale from 0- 10 as 0 means no pain and 10 worst pain and 0-3 mild pain , 4-7 moderate pain and 7-10 severe pain
The duration of analgesia before needing rescue analgesia
Time frame: First 24 hours postoperative
Time in minutes
Frequency of rescue analgesia needed
Time frame: First 24 hours postoperative
4 secondary outcomes
fetal safety
Time frame: first minute and at 5 minutes postdelivery
time needed to ambulate unaided
Time frame: the first 24 hours postoperatively
patient hemodynamics
Time frame: Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery
Patient hemodynamics
Time frame: Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery
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 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided transversus abdominis plane block in people with Postoperative Pain, run by Tamer Nabil Abdelrahman 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 3 inclusion and 14 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 Aug 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?
Efficacy of postoperative analgesia (time frame: the first 24 hours postoperative). 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 11 Aug 2020.