Postoperative PainNCT04426617
Fentanyl Versus Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block
A study testing Ultrasound Guided Transversus Abdominis Plane Block in people with Postoperative Pain, run by Bassant M. Abdelhamid at 1 site in Egypt.
Trial summary
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for various surgeries through the lower to mid-abdominal wall.The addition of fentanyl… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2020to 15 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status ASA I and ASA ll.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
- Patients undergoing Abdominal Surgeries.
- Patient is able to provide a written informed consent.
Who cannot join
- Known sensitivity to local anaesthetics.
- Significant liver or renal insufficiency.
- Contraindication to regional anaesthesia e.g. local - sepsis, pre-existing peripheral neuropathies and coagulopathy.
- Patient refusal.
- Failed Block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Fentanyl And Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Abdominal Surgeries; A Randomized Controlled Study
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions.
The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration. The aim of the work is to study the effect of the addition fentanyl and midazolam on the onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption, Time for first rescue Analgesia.
in patients undergoing simple unilateral abdominal surgeries.
Read the detailed description
Informed written consent will be obtained from study participants or their legally authorized representative. This is a randomized controlled double blinded study; patients will be enrolled in the study and will be randomized and equally divided into three groups:
Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance of Anaesthesia:
Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30 minutes.
Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and the patients will be mechanically ventilated using the appropriate setting that will keep the end-tidal CO2 at 30-35mmHg.
One reading of mean arterial pressure (MAP) and heart rate (HR) will be taken 1 minute before induction of general anaesthesia (a baseline reading), 1 minute before surgical incision and at 15-minute intervals intra operatively.
Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline (8) was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
Hypotension will be treated with 0.9% normal saline and/or 5mg ephedrine in incremental doses to maintain mean blood pressure above 70 mmHg.
The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
The patient will be transferred to the post-anaesthesia care unit (PACU) where the MAP and HR will be recorded immediately upon arrival.
Side effects such as local anaesthetic toxicity, postoperative nausea and vomiting (PONV), respiratory depression (respiratory rate <10/minute) will be recorded.
- 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
The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.
| Study group | Role | What they receive |
|---|---|---|
| fentanyle | Experimental | : patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& fentanyl). Receives: Procedure: Ultrasound Guided Transversus Abdominis Plane Block |
| Midazolam | Experimental | patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& midazolam). Receives: Procedure: Ultrasound Guided Transversus Abdominis Plane Block |
| control | Placebo comparator | patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%). 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.
Onset of the Analgesic effect of TAP block with different additives
The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.
Measured: 30 minutes
Secondary outcomes (4)
Dose of intra-Operative fentanyl consumption
Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
Measured: 2 hours
Block related complications
haematoma, neurological complications
Measured: 24 hours
Time of first analgesic request
visual analogue scale equals or more than 4
Measured: 24 hours
Incidence of postoperative nausea and vomiting
will be assessed using by yes/ no scale
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start10 Jun 2020
- Primary completion1 Feb 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassant M. Abdelhamid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- yahia hammad, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426617
- Sponsor's protocol ID
- MS-258-2019
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nehra P, Oza V, Parmar V, Fumakiya P. Effect of Addition of Fentanyl and Clonidine to Local Anesthetic Solution in Peribulbar Block. J Pharmacol Pharmacother. 2017 Jan-Mar;8(1):3-7. doi: 10.4103/jpp.JPP_109_16.
PubMed 28405129Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
PubMed 21851346Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
PubMed 29226150
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fentanyl And Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Abdominal Surgeries; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04426617
- Acronym / sponsor ID
- MS-258-2019
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bassant M. AbdelhamidUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 11 Jun 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.
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions.
The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration. The aim of the work is to study the effect of the addition fentanyl and midazolam on the onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption, Time for first rescue Analgesia.
in patients undergoing simple unilateral abdominal surgeries.
Detailed description
Informed written consent will be obtained from study participants or their legally authorized representative. This is a randomized controlled double blinded study; patients will be enrolled in the study and will be randomized and equally divided into three groups:
Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance of Anaesthesia:
Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30 minutes.
Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and the patients will be mechanically ventilated using the appropriate setting that will keep the end-tidal CO2 at 30-35mmHg.
One reading of mean arterial pressure (MAP) and heart rate (HR) will be taken 1 minute before induction of general anaesthesia (a baseline reading), 1 minute before surgical incision and at 15-minute intervals intra operatively.
Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline (8) was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
Hypotension will be treated with 0.9% normal saline and/or 5mg ephedrine in incremental doses to maintain mean blood pressure above 70 mmHg.
The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
The patient will be transferred to the post-anaesthesia care unit (PACU) where the MAP and HR will be recorded immediately upon arrival.
Side effects such as local anaesthetic toxicity, postoperative nausea and vomiting (PONV), respiratory depression (respiratory rate <10/minute) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fentanyle | Experimental | Procedure: Ultrasound Guided Transversus Abdominis Plane Block: patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& fentanyl). |
| Midazolam | Experimental | Procedure: Ultrasound Guided Transversus Abdominis Plane Blockpatients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& midazolam). |
| control | Placebo comparator | Procedure: Ultrasound Guided Transversus Abdominis Plane Blockpatients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physical status ASA I and ASA ll.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
- Patients undergoing Abdominal Surgeries.
- Patient is able to provide a written informed consent.
Key exclusion criteria (5 listed)
- Known sensitivity to local anaesthetics.
- Significant liver or renal insufficiency.
- Contraindication to regional anaesthesia e.g. local - sepsis, pre-existing peripheral neuropathies and coagulopathy.
- Patient refusal.
- Failed Block.
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 BlockThe patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane. | Procedure or surgery | Midazolam, control, fentanyle |
Primary outcome
Onset of the Analgesic effect of TAP block with different additives
Time frame: 30 minutes
The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.
4 secondary outcomes
Dose of intra-Operative fentanyl consumption
Time frame: 2 hours
Block related complications
Time frame: 24 hours
Time of first analgesic request
Time frame: 24 hours
Incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperative
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 Jul 2024.
- Background: PubMed 28405129Nehra P, Oza V, Parmar V, Fumakiya P. Effect of Addition of Fentanyl and Clonidine to Local Anesthetic Solution in Peribulbar Block. J Pharmacol Pharmacother. 2017 Jan-Mar;8(1):3-7. doi: 10.4103/jpp.JPP_109_16.
- Background: PubMed 21851346Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
- Results publication: PubMed 29226150Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
- 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.
yahia hammad, M.D. principal investigator
Cairo University
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 Bassant M. Abdelhamid 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 5 inclusion and 5 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 Jul 2024. 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?
Onset of the Analgesic effect of TAP block with different additives (time frame: 30 minutes). 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 NCT04426617, which also lists 3 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 Jul 2024.