Subcostal TAP Block for Multiport Laparoscopic CholecystectomyUGS-TAPNCT02708017
Analgesic Effect of Subcostal TAP Block
A study testing Ultrasound guided bilateral subcostal TAP block and Ultrasound guided bilateral posterior TAP block in people with Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy, run by Aga Khan University.
Trial summary
The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy
- What is being tested?
- Ultrasound guided bilateral subcostal TAP block and Ultrasound guided bilateral posterior TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Sep 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy
Who cannot join
- Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason
About this study
Official title: The Analgesic Efficacy of Ultrasound Guided Bilateral Subcostal vs. Posterior Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy
Read the detailed description
After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives.
Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.
- Being tested
- Ultrasound guided bilateral subcostal TAP block, Ultrasound guided bilateral posterior TAP block
- Keywords
- Subcostal TAP block, Posterior TAP block, Ultrasound, Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided bilateral subcostal TAP blockProcedure or surgery
Also called S-TAP Block
ultrasound guided bilateral subcostal TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray,with the help of portable ultrasound machine using probe frequency of 11 Mega Hertz,ultrasound probe was positioned parallel to the costal margin near the midline,the rectus abdominis muscle was identified ,probe was gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle identified lying posterior to the rectus muscle.the 20Gauge,100millimeter long needle was introduced at the lateral edge of the rectus muscle ,from medial to lateral,in plane of the ultrasound beam.After confirmation of the plane with saline, 20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.
Ultrasound guided bilateral posterior TAP blockProcedure or surgery
Also called P-TAP Block
ultrasound guided bilateral posterior TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray.with the help of portable ultrasound machine using probe frequency of 11Mega Hertz,ultrasound probe was positioned transversely to the abdominal wall in the midaxillary line between the iliac crest and coastal margin,and carefully moved posteriolaterally for optimal identification of plane.the 20G,100mm long needle was introduced anteriorly and in line with the probe,from medial to lateral,and advanced until it reached the fascial plane between the internal oblique and transversus abdominis muscle.upon reaching the plane ,20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| S-TAP block | Active comparator | ultrasound guided bilateral subcostal TAP block Receives: Procedure: Ultrasound guided bilateral subcostal TAP block |
| P-TAP block | Active comparator | ultrasound guided bilateral Posterior TAP block Receives: Procedure: Ultrasound guided bilateral posterior TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
To compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between two groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)
Measured: 24 hours
Secondary outcomes (4)
Mean opioid consumption postoperatively
To compare post-operative mean opioid consumption in the two groups
Measured: 24hours
Nausea , vomiting and sedation score
To compare mean post-operative nausea, vomiting and sedation scores between the two groups.
Nausea score (none = 0; mild = 1(requiring no medication); moderate = 2(requiring anti-emetics); severe = 3(unresponsive to anti-emetics) Sedation score (awake and alert =0; quietly awake = 1; asleep but easily roused = 2; deep sleep =3)
Measured: 24 hours
Surgical outcome
To compare surgical outcomes in terms of early mobilization out of bed,intake of first postoperative meal,and early discharge after 24 hours of surgery between the two groups
Measured: 24 hours
Patient satisfaction
patient satisfaction is assessed by using a questionnaire at 24hours
- Are you satisfied with the method of your pain relief? Yes / No
- Would you recommend the same method of pain relief to your family/friends? Yes / No
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcostal TAP Block for Multiport Laparoscopic CholecystectomyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Karima karam khan, Aga Khan University
- Investigators
- Karima K Khan, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708017
- Sponsor's protocol ID
- 2317-ane-ERC-12
- Acronym
- UGS-TAP
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Ultrasound Guided Bilateral Subcostal vs. Posterior Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02708017
- Acronym / sponsor ID
- UGS-TAP / 2317-ane-ERC-12
- Keywords
- Subcostal TAP block, Posterior TAP block, Ultrasound, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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 purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy
Detailed description
After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives.
Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-TAP block | Active comparator | Procedure: Ultrasound guided bilateral subcostal TAP blockultrasound guided bilateral subcostal TAP block |
| P-TAP block | Active comparator | Procedure: Ultrasound guided bilateral posterior TAP blockultrasound guided bilateral Posterior TAP block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason
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 |
|---|---|---|
| Ultrasound guided bilateral subcostal TAP blockAlso: S-TAP Blockultrasound guided bilateral subcostal TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray,with the help of portable ultrasound machine using probe frequency of 11 Mega Hertz,ultrasound probe was positioned parallel to the costal margin near the midline,the rectus abdominis muscle was identified ,probe was gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle identified lying posterior to the rectus muscle.the 20Gauge,100millimeter long needle was introduced at the lateral edge of the rectus muscle ,from medial to lateral,in plane of the ultrasound beam.After confirmation of the plane with saline, 20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen. | Procedure or surgery | S-TAP block |
| Ultrasound guided bilateral posterior TAP blockAlso: P-TAP Blockultrasound guided bilateral posterior TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray.with the help of portable ultrasound machine using probe frequency of 11Mega Hertz,ultrasound probe was positioned transversely to the abdominal wall in the midaxillary line between the iliac crest and coastal margin,and carefully moved posteriolaterally for optimal identification of plane.the 20G,100mm long needle was introduced anteriorly and in line with the probe,from medial to lateral,and advanced until it reached the fascial plane between the internal oblique and transversus abdominis muscle.upon reaching the plane ,20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen. | Procedure or surgery | P-TAP block |
Primary outcome
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
Time frame: 24 hours
To compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between two groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)
4 secondary outcomes
Mean opioid consumption postoperatively
Time frame: 24hours
Nausea , vomiting and sedation score
Time frame: 24 hours
Surgical outcome
Time frame: 24 hours
Patient satisfaction
Time frame: 24hours
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 15 Mar 2016.
- 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.
Karima K Khan, FCPS principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided bilateral subcostal TAP block and Ultrasound guided bilateral posterior TAP block in people with Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy, run by Aga Khan University.
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 1 inclusion and 1 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours (time frame: 24 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 15 Mar 2016.