Laparoscopic CholecystectomyNCT06321185
Laparoscopic Cholecystectomy and Quality of Recovery
A study testing Subcostal TAP block and Port site local anesthetic infiltration in people with Laparoscopic Cholecystectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Subcostal TAP block and Port site local anesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2024to 10 Apr 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients aged 18 to 80
- American Society of Anesthesiology (ASA) physical status I-II
- Signed informed consent
Who cannot join
- Patient refusal and inability to provide informed consent
- Known allergy to local anesthetics
- Severe kidney or liver disease
- Altered level of consciousness
- Inability to communicate due to language barrier
- Diagnosis of mental or psychiatric disorder
Show all 14Show fewer
- Presence of coagulation disorder
- Contraindications to regional anesthesia
- Contraindications to any drug applying in the study
- Presence of coagulation disorder
- Chronic opioid intake
- Body mass index (BMI) ≥ 40 kg/m2
- History of alcohol or drug abuse
- Changed surgical technique from laparoscopic to open.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
Istanbul, Fatih, 34093
About this study
Official title: The Effects of Subcostal Transversus Abdominis Plane Block and Port-site Infiltration on the Quality of Recovery of Patients Undergoing Laparoscopic Cholecystectomy
This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics.
Read the detailed description
There are current approaches that search patients' perspectives to assess postoperative outcomes. In this regard, patient-centered outcomes are evaluated in clinical trials. It is recommended that patient comfort be assessed for short-term recovery after surgery. The Quality of Recovery-15 (QoR-15) scale is a defined patient comfort endpoint. This scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 1 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores.
The subcostal transversus abdominis plane ( Subcostal TAP) block is used for analgesia in abdominal surgeries, including laparoscopic cholecystectomy. Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy.
The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy. Secondary outcomes are to evaluate Numerical Rating Scale (NRS) scores at time intervals, postoperative rescue analgesic requirement, total consumption of postoperative opioid analgesics, and presence of nausea and vomiting, for the postoperative 24 hours.
This study will be conducted as a prospective randomized clinical trial. The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After assessment for eligibility, the patients will be randomly allocated into three groups.
For the first group, a subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. For the second group, after intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. The third group will not have an intervention or local anesthetic administration, and a multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). This IV analgesic regimen will be applied to all patients included in the study. The patients will not know to which group they are allocated. Standard anesthesia protocol will be applied to all patients.
At the ward, patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam. At the Numerical Rating Scale (NRS), pain is rated on a scale from 0 (no pain) to 10 (worst pain) and will be assessed at time intervals both at rest and during movement for postoperative 24 hours. A rescue analgesic IV 50 mg tramadol will be applied if it is four or higher. The healthcare provider will be blinded to which group the patient is in. All NRS scores, the requirement for rescue analgesics and total consumption, and the presence of nausea and vomiting for the postoperative 24 hours will be recorded by blind outcome assessors.
The Quality of Recovery-15 (QoR-15) scale will be evaluated before the surgery in the waiting area and at the postoperative 24th hour in the ward. The outcome assessor questioning QoR-15 will be blinded to which group the patient is allocated to.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Subcostal TAP block, Port site local anesthetic infiltration, No intervention or local anesthetic administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal TAP blockProcedure or surgery
Subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).
Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.
Port site local anesthetic infiltrationOther
After intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).
Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.
No intervention or local anesthetic administrationOther
There will not be an intervention or local anesthetic administration. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol).
Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher.
| Study group | Role | What they receive |
|---|---|---|
| Subcostal TAP block | Active comparator | Subcostal TAP block will be applied bilaterally with 20 ml 0.25% bupivacaine for each side. Receives: Procedure: Subcostal TAP block |
| Port site local anesthetic infiltration | Active comparator | A total solution of 20 ml 0.25% bupivacaine will be infiltrated into the port sites before port placements. Receives: Other: Port site local anesthetic infiltration |
| Standard multimodal IV analgesia | Other | There will not be an intervention or local anesthetic administration. Receives: Other: No intervention or local anesthetic administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) scale
Quality of Recovery-15 scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 0 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores. Postoperative score at the 24th hour will be assessed as the primary outcome.
Measured: 24 hours
Secondary outcomes (4)
Postoperative rescue analgesic requirement
IV 50 mg tramadol will be administered as a rescue analgesic when patients Numerical Rating Scale (NRS) score is 4 and higher.
Measured: 24 hours
Consumption of postoperative opioid analgesics
IV 50 mg tramadol will be administered when patients Numerical Rating Scale (NRS) score is 4 and higher. Total given dose of tramadol will be questioned.
Measured: 24 hours
Numerical Rating Scale (NRS) scores
On the Numerical Rating Scale, pain is rated on a scale from 0 (no pain) to 10 (worst pain) and will be assessed at time intervals both at rest and during movement. Higher scores are related to severe pain.
Measured: 24 hours
Postoperative nausea and vomiting
The presence of nausea and vomiting will be recorded postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start25 Mar 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- The patients will be allocated randomly into three groups. Two groups will receive subcostal TAP block or port site local anesthetic infiltration, and the third group will not receive any intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserref Beril Dincer, Istanbul University
- Investigators
- Muserref B Dincer, Principal investigator, Istanbul University Istanbul Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321185
- Sponsor's protocol ID
- 2024/177
- Status last verified
- May 2025
- First submitted
- 14 Mar 2024
- Last updated
- 6 May 2025
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Subcostal Transversus Abdominis Plane Block and Port-site Infiltration on the Quality of Recovery of Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06321185
- Acronym / sponsor ID
- 2024/177
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 20 Mar 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.
This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics.
Detailed description
There are current approaches that search patients' perspectives to assess postoperative outcomes. In this regard, patient-centered outcomes are evaluated in clinical trials. It is recommended that patient comfort be assessed for short-term recovery after surgery. The Quality of Recovery-15 (QoR-15) scale is a defined patient comfort endpoint. This scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 1 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores.
The subcostal transversus abdominis plane ( Subcostal TAP) block is used for analgesia in abdominal surgeries, including laparoscopic cholecystectomy. Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy.
The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy. Secondary outcomes are to evaluate Numerical Rating Scale (NRS) scores at time intervals, postoperative rescue analgesic requirement, total consumption of postoperative opioid analgesics, and presence of nausea and vomiting, for the postoperative 24 hours.
This study will be conducted as a prospective randomized clinical trial. The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After assessment for eligibility, the patients will be randomly allocated into three groups.
For the first group, a subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. For the second group, after intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. The third group will not have an intervention or local anesthetic administration, and a multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). This IV analgesic regimen will be applied to all patients included in the study. The patients will not know to which group they are allocated. Standard anesthesia protocol will be applied to all patients.
At the ward, patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam. At the Numerical Rating Scale (NRS), pain is rated on a scale from 0 (no pain) to 10 (worst pain) and will be assessed at time intervals both at rest and during movement for postoperative 24 hours. A rescue analgesic IV 50 mg tramadol will be applied if it is four or higher. The healthcare provider will be blinded to which group the patient is in. All NRS scores, the requirement for rescue analgesics and total consumption, and the presence of nausea and vomiting for the postoperative 24 hours will be recorded by blind outcome assessors.
The Quality of Recovery-15 (QoR-15) scale will be evaluated before the surgery in the waiting area and at the postoperative 24th hour in the ward. The outcome assessor questioning QoR-15 will be blinded to which group the patient is allocated to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be allocated randomly into three groups. Two groups will receive subcostal TAP block or port site local anesthetic infiltration, and the third group will not receive any intervention.
| Arm | Type | Receives |
|---|---|---|
| Subcostal TAP block | Active comparator | Procedure: Subcostal TAP blockSubcostal TAP block will be applied bilaterally with 20 ml 0.25% bupivacaine for each side. |
| Port site local anesthetic infiltration | Active comparator | Other: Port site local anesthetic infiltrationA total solution of 20 ml 0.25% bupivacaine will be infiltrated into the port sites before port placements. |
| Standard multimodal IV analgesia | Other | Other: No intervention or local anesthetic administrationThere will not be an intervention or local anesthetic administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients aged 18 to 80
- American Society of Anesthesiology (ASA) physical status I-II
- Signed informed consent
Key exclusion criteria (14 listed)
- Patient refusal and inability to provide informed consent
- Known allergy to local anesthetics
- Severe kidney or liver disease
- Altered level of consciousness
- Inability to communicate due to language barrier
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 |
|---|---|---|
| Subcostal TAP blockSubcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher. | Procedure or surgery | Subcostal TAP block |
| Port site local anesthetic infiltrationAfter intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher. | Other | Port site local anesthetic infiltration |
| No intervention or local anesthetic administrationThere will not be an intervention or local anesthetic administration. A multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). Patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam at the ward. Pain severity will be assessed with a Numeric Rating Scale (NRS) rated between 0 and 10; a rescue analgesic IV 50 mg tramadol will be applied when it is four or higher. | Other | Standard multimodal IV analgesia |
Primary outcome
Quality of Recovery-15 (QoR-15) scale
Time frame: 24 hours
Quality of Recovery-15 scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 0 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores. Postoperative score at the 24th hour will be assessed as the primary outcome.
4 secondary outcomes
Postoperative rescue analgesic requirement
Time frame: 24 hours
Consumption of postoperative opioid analgesics
Time frame: 24 hours
Numerical Rating Scale (NRS) scores
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 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 6 May 2025.
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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.
Muserref B Dincer principal investigator
Istanbul University Istanbul Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal TAP block and Port site local anesthetic infiltration in people with Laparoscopic Cholecystectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
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 14 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 6 May 2025. 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 Turkey (Türkiye). 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?
Quality of Recovery-15 (QoR-15) scale (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 6 May 2025.