AnalgesiaPhase 4NCT06202664
Opioid Free Anesthesia for Laparoscopic Cholecystectomy
A Phase 4 study testing Erector Spinae Block and Opioid Analgesic in people with Analgesia, run by Muhammad Haroon Anwar at 1 site in Pakistan.
Trial summary
The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector Spinae Block and Opioid Analgesic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 31 Aug 2024
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 16 years to 80 years.
- American Society of Anesthesiologists (ASA) class: I and II.
- Elective Laparoscopic Cholecystectomy under General Anesthesia.
- Duration of surgery being less than 1h
Who cannot join
- ASA class III or above
- Neuromuscular disease
- Body mass index >35 kg/m2
- known allergy to drugs used in the study
- Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency
- Intra-operative conversion from laparoscopic to open procedure.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
About this study
Official title: Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital
The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Being a day care procedure the anesthetic technique employed should provide adequate analgesia, allow early mobilization of patient and should mitigate nausea and vomiting which occurs quite frequently in this surgical population. If these goals are achieved patients can be discharged early from hospital setting and this leads to overall cost benefits.
Read the detailed description
One of the commonest presentations to surgical department is the abdominal pain caused by gall stones. The procedure of choice for treatment of cholelithiasis is Laparoscopic Cholecystectomy; a day care surgical procedure. This is performed under General Anesthesia with Endotracheal tube. During the surgery, anesthetist provides multi-modal analgesia in the form of opioids, NSAIDs and paracetamol. The commonly used Opioids in our setting include Morphine, Fentanyl and Nalbuphine. Opioids provides excellent analgesia but are associated with a number of side effects such as sedation, euphoria or dysphoria, respiratory depression, nausea, vomiting and increase in smooth muscle tone of the gut. These side effects can significantly impair the recovery in post-operative period, leading to prolong hospital stay. As a result opioid free anesthesia could be a suitable alternative to conventional opioid anesthesia for laparoscopic cholecystectomy. By avoiding the adverse effects of opioids; Opioid free anesthesia can lead to early recovery and discharge from the hospital.
One way to provide opioid free anesthesia is by utilizing loco-regional techniques. One of the loco-regional technique which has shown some benefit in laparoscopic cholecystectomy is erector spinae block. However in the available literature the block was utilized for providing post-operative analgesia in laparoscopic cholecystectomy. This Randomized Control Trial will check the efficacy of Erector Spinae Block in providing intra-operative as well as post operative analgesia in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Analgesia
- Being tested
- Erector Spinae Block, Opioid Analgesic
- Keywords
- Opioid Free Anesthesia, Erector Spinae Block, Laparoscopic Cholecystectomy, Intraoperative Hemodynamics, Post operative analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae BlockProcedure or surgery
Also called Opioid free anesthesia
Erector Spinae block under ultrasound guidance will be administered bilaterally at T6 level. The block will be administered after induction of general anesthesia with 1mg of IV Midazolam, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. After induction patient will be placed in lateral position and then under ultrasound guidance Erector Spinae Block will be administered at T6 level. Drugs administered in the block will include 30ml of 0.25% Bupivacaine and 10ml of 1% Lignocaine (bilaterally). Skin incision for trocar insertion will be given 15 mins after administration of Erector Spinae Block.
Opioid AnalgesicDrug
Also called Conventional Opioid based analgesia
This group of patient will receive general anesthesia induction with 1mcg/kg of IV Fentanyl, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. 1g of IV paracetamol and 30 mg of IV Ketorolac will be given if intra-operative course suggest inadequate analgesia (Rise in Heart rate ± Blood Pressure by more than 20% from baseline).
| Study group | Role | What they receive |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | This will be the experimental group. Patient entering this group through computer generated random numbers will receive opioid free anesthesia in form of ultrasound guided Erector Spinae Block given bilaterally at T6 level. Receives: Procedure: Erector Spinae Block |
| Conventional Opioid group | Active comparator | Patient entering this group through computer generated random numbers will receive opioid based anesthesia. Receives: Drug: Opioid Analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Measured: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Blood Pressure
Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Measured: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery
Post operative pain control
This will be assessed using Visual Analog Scale (VAS)
Measured: This will be assessed upon patient arrival at Post anesthesia care unit and then 1 hourly interval till 6hours. The pain will be assessed both on rest as well as on cough.
Secondary outcomes (2)
Intra operative rescue Opioid consumption
This will be assessed in terms of micro-grams of Fentanyl consumed intra-operatively in addition to the amount of drug given at induction in control group.
Measured: Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery
Post operative analgesic consumption
This will be assessed in terms of amount of Tramadol, Ketorolac and Paracetamol consumed in the first 6 hours following surgery as dictated by Visual Analog Scale pain score.
Measured: From arrival in the PACU till 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled will be divided into two groups through computer generated random numbers. Standard ASA monitoring will be done. Intervention will be done at the time of induction of anesthesia that is opioid based analgesia vs Erector Spinae block bilaterally at T6 level. In both groups intra-operative rise in Heart Rate or Blood Pressure or both by more than 20% from baseline value particularly upon skin incision and generation of pneumoperitoneum will indicate inadequate analgesia. This will then be supplemented with 0.5 Mcg/kg of IV Fentanyl increments along with 1g IV Paracetamol and 30 mg IV Ketorolac . Post operatively if VAS score is greater than 4 then rescue analgesia in the form of 1g of IV Paracetamol will be given. This will be supplemented with 15 mg of IV Ketorolac if VAS score is greater than 6. IV Tramadol at dose of 50mg will be given if the VAS score is greater than 8.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Haroon Anwar
- Sponsor type
- Other government
- Collaborators
- Pakistan Institute of Medical Sciences
- Responsible party
- Sponsor-investigator, Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences
- Investigators
- Muhammad Haroon Anwar, MBBS, Principal investigator, Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202664
- Sponsor's protocol ID
- F.3-2/2022(ERRB)/PIMS
- Status last verified
- Sep 2024
- First submitted
- 1 Jan 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragupathy R, Prabhu SCG, Thiyagarajan D, Anto V. Opioid-free anaesthesia for laparoscopic surgeries - A prospective non-randomised study in a tertiary care hospital. Indian J Anaesth. 2022 Mar;66(3):207-212. doi: 10.4103/ija.ija_785_21. Epub 2022 Mar 24.
PubMed 35497703
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06202664
- Acronym / sponsor ID
- F.3-2/2022(ERRB)/PIMS
- Conditions
- Analgesia
- Keywords
- Opioid Free Anesthesia, Erector Spinae Block, Laparoscopic Cholecystectomy, Intraoperative Hemodynamics, Post operative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Muhammad Haroon AnwarOther government
- Collaborators
- Pakistan Institute of Medical Sciences
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 11 Jan 2024 (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.
The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Being a day care procedure the anesthetic technique employed should provide adequate analgesia, allow early mobilization of patient and should mitigate nausea and vomiting which occurs quite frequently in this surgical population. If these goals are achieved patients can be discharged early from hospital setting and this leads to overall cost benefits.
Detailed description
One of the commonest presentations to surgical department is the abdominal pain caused by gall stones. The procedure of choice for treatment of cholelithiasis is Laparoscopic Cholecystectomy; a day care surgical procedure. This is performed under General Anesthesia with Endotracheal tube. During the surgery, anesthetist provides multi-modal analgesia in the form of opioids, NSAIDs and paracetamol. The commonly used Opioids in our setting include Morphine, Fentanyl and Nalbuphine. Opioids provides excellent analgesia but are associated with a number of side effects such as sedation, euphoria or dysphoria, respiratory depression, nausea, vomiting and increase in smooth muscle tone of the gut. These side effects can significantly impair the recovery in post-operative period, leading to prolong hospital stay. As a result opioid free anesthesia could be a suitable alternative to conventional opioid anesthesia for laparoscopic cholecystectomy. By avoiding the adverse effects of opioids; Opioid free anesthesia can lead to early recovery and discharge from the hospital.
One way to provide opioid free anesthesia is by utilizing loco-regional techniques. One of the loco-regional technique which has shown some benefit in laparoscopic cholecystectomy is erector spinae block. However in the available literature the block was utilized for providing post-operative analgesia in laparoscopic cholecystectomy. This Randomized Control Trial will check the efficacy of Erector Spinae Block in providing intra-operative as well as post operative analgesia in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled will be divided into two groups through computer generated random numbers. Standard ASA monitoring will be done. Intervention will be done at the time of induction of anesthesia that is opioid based analgesia vs Erector Spinae block bilaterally at T6 level. In both groups intra-operative rise in Heart Rate or Blood Pressure or both by more than 20% from baseline value particularly upon skin incision and generation of pneumoperitoneum will indicate inadequate analgesia. This will then be supplemented with 0.5 Mcg/kg of IV Fentanyl increments along with 1g IV Paracetamol and 30 mg IV Ketorolac . Post operatively if VAS score is greater than 4 then rescue analgesia in the form of 1g of IV Paracetamol will be given. This will be supplemented with 15 mg of IV Ketorolac if VAS score is greater than 6. IV Tramadol at dose of 50mg will be given if the VAS score is greater than 8.
| Arm | Type | Receives |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | Procedure: Erector Spinae BlockThis will be the experimental group. Patient entering this group through computer generated random numbers will receive opioid free anesthesia in form of ultrasound guided Erector Spinae Block given bilaterally at T6 level. |
| Conventional Opioid group | Active comparator | Drug: Opioid AnalgesicPatient entering this group through computer generated random numbers will receive opioid based anesthesia. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16 years to 80 years.
- American Society of Anesthesiologists (ASA) class: I and II.
- Elective Laparoscopic Cholecystectomy under General Anesthesia.
- Duration of surgery being less than 1h
Key exclusion criteria (6 listed)
- ASA class III or above
- Neuromuscular disease
- Body mass index >35 kg/m2
- known allergy to drugs used in the study
- Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency
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 |
|---|---|---|
| Erector Spinae BlockAlso: Opioid free anesthesiaErector Spinae block under ultrasound guidance will be administered bilaterally at T6 level. The block will be administered after induction of general anesthesia with 1mg of IV Midazolam, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. After induction patient will be placed in lateral position and then under ultrasound guidance Erector Spinae Block will be administered at T6 level. Drugs administered in the block will include 30ml of 0.25% Bupivacaine and 10ml of 1% Lignocaine (bilaterally). Skin incision for trocar insertion will be given 15 mins after administration of Erector Spinae Block. | Procedure or surgery | Opioid Free Anesthesia Group |
| Opioid AnalgesicAlso: Conventional Opioid based analgesiaThis group of patient will receive general anesthesia induction with 1mcg/kg of IV Fentanyl, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. 1g of IV paracetamol and 30 mg of IV Ketorolac will be given if intra-operative course suggest inadequate analgesia (Rise in Heart rate ± Blood Pressure by more than 20% from baseline). | Drug | Conventional Opioid group |
Primary outcome
Heart Rate
Time frame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Blood Pressure
Time frame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery
Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Post operative pain control
Time frame: This will be assessed upon patient arrival at Post anesthesia care unit and then 1 hourly interval till 6hours. The pain will be assessed both on rest as well as on cough.
This will be assessed using Visual Analog Scale (VAS)
2 secondary outcomes
Intra operative rescue Opioid consumption
Time frame: Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery
Post operative analgesic consumption
Time frame: From arrival in the PACU till 6 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 1 Oct 2024.
- Results publication: PubMed 35497703Ragupathy R, Prabhu SCG, Thiyagarajan D, Anto V. Opioid-free anaesthesia for laparoscopic surgeries - A prospective non-randomised study in a tertiary care hospital. Indian J Anaesth. 2022 Mar;66(3):207-212. doi: 10.4103/ija.ija_785_21. Epub 2022 Mar 24.
- 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.
Muhammad Haroon Anwar, MBBS principal investigator
Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
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 Erector Spinae Block and Opioid Analgesic in people with Analgesia, run by Muhammad Haroon Anwar 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: finished, as of the sponsor's last update on 1 Oct 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.
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?
Heart Rate (time frame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.). The study lists 3 primary outcomes in all. 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 NCT06202664, which also lists 1 linked publication.
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 2024.