Pain, PostoperativeEarly Phase 1NCT05150756
Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
A Early Phase 1 study testing Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] and morphine sulphate (10mg/ ml ampoule) in people with Pain, Postoperative, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] and morphine sulphate (10mg/ ml ampoule)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 20 Sep 2022
- Phase
- Early Phase 1
- 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
- ASA physical status I- II
- body mass index (BMI) ˃ 35
- scheduled to undergo laparoscopic gastric bypass
Who cannot join
- Patients' refusal
- hypersensitivity to the study medications
- patients with known history of; hepatic disease, renal dysfunction
- severe renal impairment (eGFR <30ml/min/1.73m2)
- heart failure; left ventricular ejection fraction than 35%
- any cardiac dysrhythmias; Adam-Stokes syndrome; Wolff- Parkinson-White syndrome, atrio-ventricular block with heart rate below 50 bpm
Show all 9Show fewer
- chronic pain
- concomitantly taking beta blocking drugs •substance abuse disorder
- chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. If it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted.
Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS) profile. Its postoperative analgesia may last after reduction of its plasma concentration. So, lidocaine could be a good alternative in bariatric surgery.
Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.
Read the detailed description
compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in laparoscopic gastric bypass surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE], morphine sulphate (10mg/ ml ampoule)
- Keywords
- lidocaine, morphine, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]Drug
Also called Xylocaine 2%
At induction of anesthesia, patients will receive a loading dose of 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% till the end of surgery
morphine sulphate (10mg/ ml ampoule)Drug
At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group Lidocaine | Active comparator | At induction of anesthesia, patients will receive a loading dose of intravenous (IV) 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% via infusion pump. The infusion will be continued till the end of surgery. Receives: Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] |
| Group Morphine | Active comparator | At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery Receives: Drug: morphine sulphate (10mg/ ml ampoule) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score at rest
Intensity of pain will be monitored ; on arrival to the PACU, at 20, 40 and 60 minutes after arrival to the PACU by the Numeric Pain Rating Scale. The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of pain felt.Where 0 is no pain felt and 10 is the worst pain.
Measured: 1hour
Secondary outcomes (12)
Duration of surgery
measured in minutes
Measured: 3 hours
Duration of anesthesia
measured in minutes
Measured: 4 hours
mean values of mean blood pressure (MBP)
mean values of MBP will be recorded as base line value, before induction of anesthesia, 5 minutes after endotracheal intubation, before pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 5 hours
Number of patients requiring intra-operative morphine
Number of patients requiring intra-operative morphine will be recorded
Measured: 4hours
sPO2
recorded in the induction room and in the PACU.
Measured: 5 hours
Respiratory rate
recorded in the induction room and in the PACU
Measured: 5 hours
Post-operative nausea and/or vomiting
number of patients will be recorded
Measured: 1 hour
Post-operative sedation score
From 0 to 4
Measured: 1 hour
Modified Aldrete Score
score from 0 to 10. Higher score means patient is fit to transfer to the ward. In the PACU, patients with score ≥ 9 will be transferred to the surgical unit
Measured: 1 hour
mean values of heart rate (HR)
mean values of HR will be recorded as base line value, before induction of anesthesia, 5 minutes after endotracheal intubation, before pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU
Measured: 5 hours
Number of patients requiring postoperative additional morphine doses
Number of patients requiring postoperative additional morphine doses willbe recorded
Measured: 1 hour
the total dose of morphine given to each patient
the total dose of morphine given to each patient will be recorded in milligrams
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2022
- Primary completion28 Jul 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150756
- Sponsor's protocol ID
- R 35/ 2021
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2021
- Last updated
- 25 Oct 2022
- Results posted
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT05150756
- Acronym / sponsor ID
- R 35/ 2021
- Conditions
- Pain, Postoperative
- Keywords
- lidocaine, morphine, analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 9 Dec 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.
Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. If it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted.
Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS) profile. Its postoperative analgesia may last after reduction of its plasma concentration. So, lidocaine could be a good alternative in bariatric surgery.
Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.
Detailed description
compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in laparoscopic gastric bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Lidocaine | Active comparator | Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]At induction of anesthesia, patients will receive a loading dose of intravenous (IV) 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% via infusion pump. The infusion will be continued till the end of surgery. |
| Group Morphine | Active comparator | Drug: morphine sulphate (10mg/ ml ampoule)At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I- II
- body mass index (BMI) ˃ 35
- scheduled to undergo laparoscopic gastric bypass
Key exclusion criteria (9 listed)
- Patients' refusal
- hypersensitivity to the study medications
- patients with known history of; hepatic disease, renal dysfunction
- severe renal impairment (eGFR <30ml/min/1.73m2)
- heart failure; left ventricular ejection fraction than 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 |
|---|---|---|
| Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]Also: Xylocaine 2%At induction of anesthesia, patients will receive a loading dose of 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% till the end of surgery | Drug | Group Lidocaine |
| morphine sulphate (10mg/ ml ampoule)At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery | Drug | Group Morphine |
Primary outcome
Post-operative pain score at rest
Time frame: 1hour
Intensity of pain will be monitored ; on arrival to the PACU, at 20, 40 and 60 minutes after arrival to the PACU by the Numeric Pain Rating Scale. The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of pain felt.Where 0 is no pain felt and 10 is the worst pain.
12 secondary outcomes
Duration of surgery
Time frame: 3 hours
Duration of anesthesia
Time frame: 4 hours
mean values of mean blood pressure (MBP)
Time frame: 5 hours
Number of patients requiring intra-operative morphine
Time frame: 4hours
sPO2
Time frame: 5 hours
Respiratory rate
Time frame: 5 hours
Post-operative nausea and/or vomiting
Time frame: 1 hour
Post-operative sedation score
Time frame: 1 hour
Modified Aldrete Score
Time frame: 1 hour
mean values of heart rate (HR)
Time frame: 5 hours
Number of patients requiring postoperative additional morphine doses
Time frame: 1 hour
the total dose of morphine given to each patient
Time frame: 5 hours
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 25 Oct 2022.
- 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 Early Phase 1 study testing Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] and morphine sulphate (10mg/ ml ampoule) in people with Pain, Postoperative, run by Ain Shams 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 9 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 25 Oct 2022. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Post-operative pain score at rest (time frame: 1hour). 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 25 Oct 2022.