AnalgesiaNCT05995301
Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
A study testing Ropivacaine in Transversus abdominis plane and Ropivacaine in Local infiltration at port site in people with Analgesia and Ropivacaine, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
Trial summary
The goal of this clinical trial is to compare the postoperative analgesic efficacy of ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Analgesia, Ropivacaine, Laparoscopic Abdominal Surgery
- What is being tested?
- Ropivacaine in Transversus abdominis plane and Ropivacaine in Local infiltration at port site
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 12 Mar 2022to 25 Feb 2023
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either sex aged 25-70 years
- ASA physical status I or II
- Patient posted for elective abdominal laparoscopic surgery.
Who cannot join
- Any absolute contraindications to peripheral nerve blockade
- History of Hypersensitivity to Drugs
- Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure
- History of neuromuscular or psychiatric disease
- Patient receiving psychotropic drug, chronic analgesic therapy
- Pregnancy
- Patient weight less than 50 kg
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the postoperative analgesic efficacy of ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients undergoing laparoscopic surgery. The main question it aims to answer is:
- If Transversus Abdominis Plane block with Ropivacaine will produce long duration of analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic abdominal surgery .
Read the detailed description
Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is distressing and detrimental in post-operative patients. Management of post-operative pain has been a challenge to anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease length of stay, reduced hospital costs, increased patient satisfaction, increase productivity and quality of life.
Peripheral nerve blockade or field block with local anesthesia is helpful in managing postoperative pain effectively whilst avoiding complication associated with intravenous narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency of intravenous narcotics used in postoperative period, hence minimizing the side effects of narcotics.
Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that results in anesthesia of the abdominal wall. This plane represents an anatomical potential space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia following laparoscopic surgery.
Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side) expecting to cover the upper abdomen when TAP block is performed via posterior approach.
NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis Plane block and local anesthetic infiltration after laparoscopicabdominal surgery
General objective
- To compare the efficacy of Transversus Abdominal plane block and local anesthetic infiltration after laparoscopic abdominal surgery
Specific objective
- To compare the visual analog score (VAS) between two groups
- To compare time to first analgesic requirement between two groups.
- To compare the total dose of analgesia in 24 hours between the two groups
- Being tested
- Ropivacaine in Transversus abdominis plane, Ropivacaine in Local infiltration at port site
- Keywords
- Ropivacaine, TAP Block, Analgesia, Laparoscopic abdominal surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine in Transversus abdominis planeDrug
This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery
Ropivacaine in Local infiltration at port siteDrug
This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Transversus Abdominis Plane block Receives: Drug: Ropivacaine in Transversus abdominis plane |
| Group II | Experimental | Local infiltration Receives: Drug: Ropivacaine in Local infiltration at port site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Visual analog scale at rest
Measured: Time Frame: upto first 24 hour after intervention
Secondary outcomes (1)
Duration of analgesia
Visual analog scale on movement
Measured: Time Frame: upto first 24 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start12 Mar 2022
- Primary completion12 Nov 2022
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Academy of Medical Sciences, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Surendra Bhusal, National Academy of Medical Sciences, Nepal
- Investigators
- Surendra Bhusal, MD, Principal investigator, NAMS Bir HospitalBrihaspati K C, MD, Study director, NAMS Bir HospitalKaushal Tamang, MD, Study chair, NAMS Bir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995301
- Sponsor's protocol ID
- NAMS Bir Hospital
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05995301
- Acronym / sponsor ID
- NAMS Bir Hospital
- Keywords
- Ropivacaine, TAP Block, Analgesia, Laparoscopic abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Academy of Medical Sciences, NepalOther government
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 16 Aug 2023 (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 clinical trial is to compare the postoperative analgesic efficacy of ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients undergoing laparoscopic surgery. The main question it aims to answer is:
- If Transversus Abdominis Plane block with Ropivacaine will produce long duration of analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic abdominal surgery .
Detailed description
Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is distressing and detrimental in post-operative patients. Management of post-operative pain has been a challenge to anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease length of stay, reduced hospital costs, increased patient satisfaction, increase productivity and quality of life.
Peripheral nerve blockade or field block with local anesthesia is helpful in managing postoperative pain effectively whilst avoiding complication associated with intravenous narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency of intravenous narcotics used in postoperative period, hence minimizing the side effects of narcotics.
Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that results in anesthesia of the abdominal wall. This plane represents an anatomical potential space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia following laparoscopic surgery.
Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side) expecting to cover the upper abdomen when TAP block is performed via posterior approach.
NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis Plane block and local anesthetic infiltration after laparoscopicabdominal surgery
General objective
- To compare the efficacy of Transversus Abdominal plane block and local anesthetic infiltration after laparoscopic abdominal surgery
Specific objective
- To compare the visual analog score (VAS) between two groups
- To compare time to first analgesic requirement between two groups.
- To compare the total dose of analgesia in 24 hours between the two groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Ropivacaine in Transversus abdominis planeTransversus Abdominis Plane block |
| Group II | Experimental | Drug: Ropivacaine in Local infiltration at port siteLocal infiltration |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of either sex aged 25-70 years
- ASA physical status I or II
- Patient posted for elective abdominal laparoscopic surgery.
Key exclusion criteria (7 listed)
- Any absolute contraindications to peripheral nerve blockade
- History of Hypersensitivity to Drugs
- Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure
- History of neuromuscular or psychiatric disease
- Patient receiving psychotropic drug, chronic analgesic therapy
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 |
|---|---|---|
| Ropivacaine in Transversus abdominis planeThis group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery | Drug | Group I |
| Ropivacaine in Local infiltration at port siteThis group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery | Drug | Group II |
Primary outcome
Duration of analgesia
Time frame: Time Frame: upto first 24 hour after intervention
Visual analog scale at rest
1 secondary outcome
Duration of analgesia
Time frame: Time Frame: upto first 24 hour after intervention
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 28 Aug 2023.
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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.
Surendra Bhusal, MD principal investigator
NAMS Bir Hospital
Brihaspati K C, MD study director
NAMS Bir Hospital
Kaushal Tamang, MD study chair
NAMS Bir Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in Transversus abdominis plane and Ropivacaine in Local infiltration at port site in people with Analgesia and Ropivacaine, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
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 7 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 28 Aug 2023. 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 Nepal. 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?
Duration of analgesia (time frame: Time Frame: upto first 24 hour after intervention). 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 28 Aug 2023.