Post Operative PainNCT05231941
Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
A study testing Lidocaine IV and Ropivacaine in people with Post Operative Pain, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Lidocaine IV and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2022to 17 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age group (18-65)
- Undergoing elective Laproscopic Cholecystectomy
- ASA status I or II
Who cannot join
- Participation in any other trial
- Known hypersensitivity to study medications
- Chronic Opioid used
- Seizure disorder
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.
- Conditions
- Post Operative Pain
- Being tested
- Lidocaine IV, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
Bolus and infusion of lidocaine will be administered
RopivacaineDrug
Bilateral TAP block will be given to these patients
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | After induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery. Receives: Drug: Lidocaine IV |
| TAP group | Experimental | After completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally. Receives: Drug: Ropivacaine |
| Control group | No intervention | No additional intervention will be given to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: On arrival in PACU (0 hours)
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: At 2 hours
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: At 4 hours
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: At 6 hours
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: At 12 hours
Pain Score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Measured: At 24 hours
Secondary outcomes (2)
Post operative nausea and vomiting
Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting)
Measured: On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
Patient Satisfaction
Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree)
Measured: At 24 hours or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start25 Feb 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haris Sheikh, Aga Khan University Hospital, Pakistan
- Investigators
- Haris Sheikh, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231941
- Sponsor's protocol ID
- 5515
- Status last verified
- Jun 2024
- First submitted
- 19 Jan 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05231941
- Acronym / sponsor ID
- 5515
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 9 Feb 2022 (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.
This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine IVAfter induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery. |
| TAP group | Experimental | Drug: RopivacaineAfter completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally. |
| Control group | No intervention | –No additional intervention will be given to this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age group (18-65)
- Undergoing elective Laproscopic Cholecystectomy
- ASA status I or II
Key exclusion criteria (4 listed)
- Participation in any other trial
- Known hypersensitivity to study medications
- Chronic Opioid used
- Seizure disorder
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 IVBolus and infusion of lidocaine will be administered | Drug | Lidocaine Group |
| RopivacaineBilateral TAP block will be given to these patients | Drug | TAP group |
Primary outcome
Pain score
Time frame: On arrival in PACU (0 hours)
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Time frame: At 2 hours
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Time frame: At 4 hours
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Time frame: At 6 hours
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Time frame: At 12 hours
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain Score
Time frame: At 24 hours
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
2 secondary outcomes
Post operative nausea and vomiting
Time frame: On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
Patient Satisfaction
Time frame: At 24 hours or discharge
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 26 Jun 2024.
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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.
Haris Sheikh, MBBS principal investigator
Aga Khan 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 Lidocaine IV and Ropivacaine in people with Post Operative Pain, run by Aga Khan University Hospital, Pakistan 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 3 inclusion and 4 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 26 Jun 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 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. 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?
Pain score (time frame: On arrival in PACU (0 hours)). The study lists 6 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 26 Jun 2024.