Postoperative PainPhase 4NCT04752111
Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.
A Phase 4 study testing Esmolol in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
Trial summary
Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2021to 20 Jul 2021
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA grade I/II patients undergoing laparoscopic cholecystectomy .
- Age group of 18 -60 years.
- Patients giving valid informed consent.
Who cannot join
- Patient refusal
- Patients belonging to ASA grade III and grade IV .
- Coagulation disorders.
- Patients with known allergy to one of the used drugs.
- Extreme obesity (BMI >35)
- Patients with cardiac, pulmonary, hepatic or renal disorders
- Pregnancy
- Drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Esmolol Infusion Have an Adjuvant Effect to Transversus Abdominis Plane Block for Pain Control in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.
Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
- Conditions
- Postoperative Pain
- Being tested
- Esmolol
- Keywords
- Esmolol infusion, TAP block, cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
administration of a loading dose esmolol infusion 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group E (esmolol infusion) | Experimental | 10 minutes before induction of anesthesia the patients will receive a loading dose of injection esmolol 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side . Receives: Drug: Esmolol |
| Group T (TAP block) | Placebo comparator | 10 minutes before induction of anesthesia the patients will receive a loading dose of injection 30 ml isotonic saline in the iv line, followed by an IV infusion of saline at a rate of 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side. Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain rescue-analgesia consumption
. If pain score exceed 3, rescue analgesia 5 mg bolus of morphine will be administered intravenous to achieve satisfactory pain control that can be repeated every 4-6 hours.
Measured: 24 hours postoperative
Secondary outcomes (4)
Visual analogue pain score
scales from zero (no pain) to ten (unbearable pain)
Measured: every 0,2,4,6,12, up to 24 hours postoperative
Intraoperative hemodynamic data
mean arterial blood pressure and heart rate
Measured: 30 minutes after induction of anesthesia
Postoperative nausea and vomiting
A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting. Ondansetron 4 mg will be available if required.
Measured: 24 hours postoperative
Patient satisfaction
using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").
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 posted12 Feb 2021
- Study start19 Jan 2021
- Primary completion15 Jun 2021
- Study completion20 Jul 2021
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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752111
- Sponsor's protocol ID
- RC3-12-2020
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Esmolol Infusion Have an Adjuvant Effect to Transversus Abdominis Plane Block for Pain Control in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.
- ClinicalTrials.gov ID
- NCT04752111
- Acronym / sponsor ID
- RC3-12-2020
- Conditions
- Postoperative Pain
- Keywords
- Esmolol infusion, TAP block, cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 12 Feb 2021 (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 after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E (esmolol infusion) | Experimental | Drug: Esmolol10 minutes before induction of anesthesia the patients will receive a loading dose of injection esmolol 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side . |
| Group T (TAP block) | Placebo comparator | Drug: Esmolol10 minutes before induction of anesthesia the patients will receive a loading dose of injection 30 ml isotonic saline in the iv line, followed by an IV infusion of saline at a rate of 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA grade I/II patients undergoing laparoscopic cholecystectomy .
- Age group of 18 -60 years.
- Patients giving valid informed consent.
Key exclusion criteria (8 listed)
- Patient refusal
- Patients belonging to ASA grade III and grade IV .
- Coagulation disorders.
- Patients with known allergy to one of the used drugs.
- Extreme obesity (BMI >35)
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 |
|---|---|---|
| Esmololadministration of a loading dose esmolol infusion 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery | Drug | Group E (esmolol infusion), Group T (TAP block) |
Primary outcome
pain rescue-analgesia consumption
Time frame: 24 hours postoperative
. If pain score exceed 3, rescue analgesia 5 mg bolus of morphine will be administered intravenous to achieve satisfactory pain control that can be repeated every 4-6 hours.
4 secondary outcomes
Visual analogue pain score
Time frame: every 0,2,4,6,12, up to 24 hours postoperative
Intraoperative hemodynamic data
Time frame: 30 minutes after induction of anesthesia
Postoperative nausea and vomiting
Time frame: 24 hours postoperative
Patient satisfaction
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 1 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Esmolol in people with Postoperative Pain, run by Benha University 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 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 1 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain rescue-analgesia consumption (time frame: 24 hours postoperative). 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 1 Oct 2021.