Side Effects of Opoid ConsumptionNCT07419815
IV Lidocaine Infusion Versus Placebo for Pain Control in Staging Laparoscopy Cases
A study testing Lidocaine Infusion and Normal Saline in people with Side Effects of Opoid Consumption, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
IV lidocaine infusion is being used as an analgesic adjunct, since we are a opioid depleted country we are using lidocaine to decrease opioid consumption and avoid the side effects such nausea, vomiting and respiratory depression associated with morphine consumption. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Side Effects of Opoid Consumption
- What is being tested?
- Lidocaine Infusion and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Dec 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 to 60 years.
- American Society of Anesthesiologists grade 1 and 2 patients.
- Both Genders
- Elective staging Laparoscopy
Who cannot join
- Patients allergic to lidocaine.
- Patients refusal.
- Patients having a history of chronic pain.
- Patients already using opioids for pain control
- Use of suxamethonium.
- Procedures taking longer than 60 minutes
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanam Memorial Cancer Hospital & Research Centre
Lahore, Punjab Province, 54470
About this study
Official title: Intravenous Lidocaine Infusion Versus Placebo, for Post Operative Acute Pain Control in Patients Undergoing Staging Laparoscopy
IV lidocaine infusion is being used as an analgesic adjunct, since we are a opioid depleted country we are using lidocaine to decrease opioid consumption and avoid the side effects such nausea, vomiting and respiratory depression associated with morphine consumption. We have given the option of rescue analgesia to the anesthetist if the clinical scenario demands.
Read the detailed description
Total of 62 patients with 31 in each group will be selected after approval from Scientific Review Committee and Institutional review board. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either into group A (IV lidocaine) or group B (saline infusion). Lidocaine will be prepared in 50 ml syringes having concentration of 4mg per ml. All lidocaine and placebo administration in our patients will be through syringe pump having 50 cc syringes. Patients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour), while patients in Group B will be given normal saline bolus and infusion at same rate during surgery. The infusion will be stopped when surgeons start closing the incision. Operations taking more than 60 minutes will be excluded from the final conclusion of results to prevent drug dose related confounding. Drug syringes for both the groups will be prepared by the researcher with the anesthetist and nurses being blind to the groups. In both group of patient's induction of anesthesia will be done using titrated dose of propofol, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg to blunt intubation response. Both group of patients will receive intravenous paracetamol 20mg/kg (maximum dose 1 gram) and diclofenac 75 mg (excluding the patients having contra indications to NSAID administration. At the end of procedure patients will be shifted to post anesthesia care unit and observed for pain. The anesthetist at his/her own discretion can use a total of 0.05-0.1 mg/kg dose of morphine given intravenously to control pain intraoperatively Pain score using numeric rating scale (NRS) will be noted at arrival, 2 hours and 4 hours post operatively. Rescue analgesia, intra venous morphine (0.1 mg/kg) will be administered if pain score is greater than >3 in recovery area Data will be recorded on a Performa attached at the end.
- Conditions
- Side Effects of Opoid Consumption
- Being tested
- Lidocaine Infusion, Normal Saline
- Keywords
- mean pain score, acute pain, mean morphine consumption
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine InfusionDrug
Patients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour)
Normal SalineDrug
patients in Group B will be given normal saline bolus and infusion at same rate during surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This arm will receive Lidocaine infusion Receives: Drug: Lidocaine Infusion |
| Group B | Placebo comparator | This arm will receive placebo Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score
Pain score using numeric rating scale will be noted at arrival, 2 hours
Measured: 2 hours
Secondary outcomes (1)
Mean morphine consumption
Mean morphine consumption will be recorded in milligrams
Measured: 2 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start3 Dec 2025
- Primary completion22 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side Effects of Opoid ConsumptionStudies 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
- Model description
- Randomized controlled trial. One group will recieve lidocaine infusion and other group will reciev placebo. option of rescue analgesia will be given to both groups if needed.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Almas Iqbal, MBBS, MBA, FRCA, Study chair, Shaukat Khanam Memorial Cancer Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419815
- Sponsor's protocol ID
- IRB-24-24
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 24 Aug 2026
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine Infusion Versus Placebo, for Post Operative Acute Pain Control in Patients Undergoing Staging Laparoscopy
- ClinicalTrials.gov ID
- NCT07419815
- Acronym / sponsor ID
- IRB-24-24
- Conditions
- Side Effects of Opoid Consumption
- Keywords
- mean pain score, acute pain, mean morphine consumption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 22 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
IV lidocaine infusion is being used as an analgesic adjunct, since we are a opioid depleted country we are using lidocaine to decrease opioid consumption and avoid the side effects such nausea, vomiting and respiratory depression associated with morphine consumption. We have given the option of rescue analgesia to the anesthetist if the clinical scenario demands.
Detailed description
Total of 62 patients with 31 in each group will be selected after approval from Scientific Review Committee and Institutional review board. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either into group A (IV lidocaine) or group B (saline infusion). Lidocaine will be prepared in 50 ml syringes having concentration of 4mg per ml. All lidocaine and placebo administration in our patients will be through syringe pump having 50 cc syringes. Patients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour), while patients in Group B will be given normal saline bolus and infusion at same rate during surgery. The infusion will be stopped when surgeons start closing the incision. Operations taking more than 60 minutes will be excluded from the final conclusion of results to prevent drug dose related confounding. Drug syringes for both the groups will be prepared by the researcher with the anesthetist and nurses being blind to the groups. In both group of patient's induction of anesthesia will be done using titrated dose of propofol, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg to blunt intubation response. Both group of patients will receive intravenous paracetamol 20mg/kg (maximum dose 1 gram) and diclofenac 75 mg (excluding the patients having contra indications to NSAID administration. At the end of procedure patients will be shifted to post anesthesia care unit and observed for pain. The anesthetist at his/her own discretion can use a total of 0.05-0.1 mg/kg dose of morphine given intravenously to control pain intraoperatively Pain score using numeric rating scale (NRS) will be noted at arrival, 2 hours and 4 hours post operatively. Rescue analgesia, intra venous morphine (0.1 mg/kg) will be administered if pain score is greater than >3 in recovery area Data will be recorded on a Performa attached at the end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial. One group will recieve lidocaine infusion and other group will reciev placebo. option of rescue analgesia will be given to both groups if needed.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Lidocaine InfusionThis arm will receive Lidocaine infusion |
| Group B | Placebo comparator | Drug: Normal SalineThis arm will receive placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 to 60 years.
- American Society of Anesthesiologists grade 1 and 2 patients.
- Both Genders
- Elective staging Laparoscopy
Key exclusion criteria (6 listed)
- Patients allergic to lidocaine.
- Patients refusal.
- Patients having a history of chronic pain.
- Patients already using opioids for pain control
- Use of suxamethonium.
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 InfusionPatients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour) | Drug | Group A |
| Normal Salinepatients in Group B will be given normal saline bolus and infusion at same rate during surgery | Drug | Group B |
Primary outcome
Mean pain score
Time frame: 2 hours
Pain score using numeric rating scale will be noted at arrival, 2 hours
1 secondary outcome
Mean morphine consumption
Time frame: 2 hours post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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.
Dr. Almas Iqbal, MBBS, MBA, FRCA study chair
Shaukat Khanam Memorial Cancer Hospital & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Infusion and Normal Saline in people with Side Effects of Opoid Consumption, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean pain score (time frame: 2 hours). 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 24 Aug 2026.