Postoperative PainNCT06326281
Postoperative Pain Management in Laparoscopic Cholecystectomies
A study testing unilateral external oblique intercostal plane block group, unilateral oblique subcostal transversus abdomınıs plane block group and Local anesthetic infiltration group in people with Postoperative Pain and Regional Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Regional Anesthesia
- What is being tested?
- unilateral external oblique intercostal plane block group, unilateral oblique subcostal transversus abdomınıs plane block group and Local anesthetic infiltration group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 20 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65
- Patients undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists score 1-2 patients
- Body mass index ) <35kg/m2
- Patients whose consent was obtained before the procedure
Who cannot join
- Patients under the age of 18 and over the age of 65
- American Society of Anesthesiologists score III and above
- Surgeries with an operating time exceeding 120 minutes
- Emergency surgeries
- Those who have had abdominal surgery
- Pregnant or breastfeeding patients
Show all 14Show fewer
- Those who have coagulopathy and use anticoagulant drugs
- Those who are allergic to local anesthetics
- Those with localized infection at the injection site
- Patients who do not have the ability to use patient controlled analgesia and evaluate Numerical rating scale
- Patients with peripheral nerve disease
- Patients with renal failure and congestive heart failure
- Patients undergoing elective laparoscopic cholecystectomy due to malignancy
- Surgeries where open surgery is performed during the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of External Oblique Intercostal Plane Block Oblique Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration Methods in Laparoscopic Cholecystectomies
This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.
It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction.
Read the detailed description
Postoperative pain is an acute pain that begins with surgical trauma and gradually decreases with tissue healing, and its elimination is important for ideal patient care after surgery. Postoperative pain; It varies depending on the type of surgery, the patient, and the need and type of analgesic in the intraoperative period. Although there have been new developments in recent years to relieve postoperative pain, studies have shown that 25% of patients can receive adequate postoperative pain treatment.The increase in thromboembolic, cardiac and respiratory complications caused by untreatable postoperative pain is one of the most important problems in operated patients.
Laparoscopic cholecystectomy; It is one of the most frequently performed surgical procedures in adult patients, and different types of pain such as parietal, visceral and somatic (shoulder pain) can be observed due to tissue damage after laparoscopic cholecystectomy, postoperative pain, diaphragmatic irritation and residual pneumoperitoneum.Multimodal analgesia in laparoscopic cholecystectomies; It can be provided with combinations of regional anesthesia techniques, incision site local anesthetic applications, intravenous opioids, nonsteroidal anti-inflammatory drugs, paracetamol and preemptive analgesia methods.
Regional anesthesia techniques have become more popular recently for the purpose of postoperative pain control, and regional anesthesia techniques in laparoscopic cholecystectomy such as epidural block, paravertebral block, transversus abdominis plan (TAP) block and External Oblique Intercostal Plan (EOIP) block, whose effectiveness has been shown by new studies. Includes methods.
Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined as a modified version of the TAP block used especially in upper abdominal surgeries such as Laparoscopic cholecystectomy.EOIP block is a new regional anesthesia technique that can provide analgesia in the postoperative period in upper abdominal abdominal surgery, which was demonstrated by anatomical studies in 2021.
EOIP block, the spread of regional anesthesia to the lateral and anterior cutaneous branches of T6/7 and T10/11, the origin of the intercostal nerves, constitutes the mechanism of this technique and shows that Laparoscopic cholecystectomies can be effective in postoperative analgesia management.
Regional anesthesia methods are frequently used in our clinic for patients undergoing upper abdominal surgery for analgesia. In this study, the investigators aimed to compare the EOIP block, OSTAP block and local anesthetic infiltration methods in laparoscopic cholecystectomy in terms of pain effectiveness in the postoperative period.
- Conditions
- Postoperative Pain, Regional Anesthesia
- Being tested
- unilateral external oblique intercostal plane block group, unilateral oblique subcostal transversus abdomınıs plane block group, Local anesthetic infiltration group, Control group
- Keywords
- regional anesthesia, laparoscopic cholecystectomy, external oblique intercostal plane block, postoperative pain, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral external oblique intercostal plane block groupProcedure or surgery
USG guided external oblique intercostal plane block will perform unilateral with Bupivacaine 25 patient included and patients were observed for pain for 24 hours
unilateral oblique subcostal transversus abdomınıs plane block groupProcedure or surgery
USG guided oblique subcostal transversus abdomınıs plane block block will perform unilateral with Bupivacaine. 25 patient included and patients were observed for pain for 24 hours
Local anesthetic infiltration groupProcedure or surgery
Bupivacaine infiltration will be performed to trocar insertion sites. 25 patient included and patients were observed for pain for 24 hours
Control groupDrug
Also called intravenous patient controlled analgesia group with tramadol
All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) patient controlled analgesias were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal plane block group | Active comparator | Before general anaesthesia, Ultrasound guided unilateral external oblique intercostal plane block group block will perform with 20 ml of 0.25% bupivacaine .Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. Receives: Procedure: unilateral external oblique intercostal plane block group |
| Oblique subcostal transversus abdomınıs plane block group | Active comparator | Under general anaesthesia, Ultrasound guided unilateral oblique subcostal transversus abdomınıs plane block will perform with 20 ml of 0.25% bupivacaine. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours Receives: Procedure: unilateral oblique subcostal transversus abdomınıs plane block group |
| Local anesthetic infiltration group | Active comparator | 4 trocars will be used by the surgical team during the operation, and these trocars will be placed 10 mm infraumbilical, 10 mm in the middle epigastrium, 5 cm below the xiphoid, 5 mm in the midclavicular line and in the right subcostal region, and 5 mm in the anterior axillary line. Before trocar placement, 0.25% bupivacaine will be applied to the skin, fascia, muscle and preperitoneal area in accordance with the infiltration rules. A total of 20 mL of 0.25% bupivacaine will be used, 6 mL for 10 mm trocar sites and 4 mL for 5 mm trocar sites. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours Receives: Procedure: Local anesthetic infiltration group |
| Control Group | Sham comparator | All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) Patient controlled analgesia protocols were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of postoperative opioid use
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours
Measured: 24 hours
Finding out which method is more effective according to the Numerical Rating Scale (0-10)
To find out which method provides more effective analgesia according to the Numeric Rating Scale patients followed for 24 hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale.
0 is no pain and 10 is the worst pain
Measured: 24 hours
Secondary outcomes (2)
postoperative nause and vomiting
The patient with nausea and vomiting will be recorded
postoperative nausea and vomiting; will be evaluated as present or absent
Measured: 24 hours
postoperative shoulder pain
The patient with shoulder pain will be recorded
postoperative shoulder pain; will be evaluated as present or absent
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 posted22 Mar 2024
- Study start20 Mar 2024
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Model description
- Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selahattin Buğra Kurtoğlu, Ankara City Hospital Bilkent
- Investigators
- Buğra Kurtoğlu, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326281
- Sponsor's protocol ID
- ACHBILKENT-ANEST-BK-01
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of External Oblique Intercostal Plane Block Oblique Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration Methods in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT06326281
- Acronym / sponsor ID
- ACHBILKENT-ANEST-BK-01
- Conditions
- Postoperative Pain, Regional Anesthesia
- Keywords
- regional anesthesia, laparoscopic cholecystectomy, external oblique intercostal plane block, postoperative pain, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 22 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 study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.
It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction.
Detailed description
Postoperative pain is an acute pain that begins with surgical trauma and gradually decreases with tissue healing, and its elimination is important for ideal patient care after surgery. Postoperative pain; It varies depending on the type of surgery, the patient, and the need and type of analgesic in the intraoperative period. Although there have been new developments in recent years to relieve postoperative pain, studies have shown that 25% of patients can receive adequate postoperative pain treatment.The increase in thromboembolic, cardiac and respiratory complications caused by untreatable postoperative pain is one of the most important problems in operated patients.
Laparoscopic cholecystectomy; It is one of the most frequently performed surgical procedures in adult patients, and different types of pain such as parietal, visceral and somatic (shoulder pain) can be observed due to tissue damage after laparoscopic cholecystectomy, postoperative pain, diaphragmatic irritation and residual pneumoperitoneum.Multimodal analgesia in laparoscopic cholecystectomies; It can be provided with combinations of regional anesthesia techniques, incision site local anesthetic applications, intravenous opioids, nonsteroidal anti-inflammatory drugs, paracetamol and preemptive analgesia methods.
Regional anesthesia techniques have become more popular recently for the purpose of postoperative pain control, and regional anesthesia techniques in laparoscopic cholecystectomy such as epidural block, paravertebral block, transversus abdominis plan (TAP) block and External Oblique Intercostal Plan (EOIP) block, whose effectiveness has been shown by new studies. Includes methods.
Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined as a modified version of the TAP block used especially in upper abdominal surgeries such as Laparoscopic cholecystectomy.EOIP block is a new regional anesthesia technique that can provide analgesia in the postoperative period in upper abdominal abdominal surgery, which was demonstrated by anatomical studies in 2021.
EOIP block, the spread of regional anesthesia to the lateral and anterior cutaneous branches of T6/7 and T10/11, the origin of the intercostal nerves, constitutes the mechanism of this technique and shows that Laparoscopic cholecystectomies can be effective in postoperative analgesia management.
Regional anesthesia methods are frequently used in our clinic for patients undergoing upper abdominal surgery for analgesia. In this study, the investigators aimed to compare the EOIP block, OSTAP block and local anesthetic infiltration methods in laparoscopic cholecystectomy in terms of pain effectiveness in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal plane block group | Active comparator | Procedure: unilateral external oblique intercostal plane block groupBefore general anaesthesia, Ultrasound guided unilateral external oblique intercostal plane block group block will perform with 20 ml of 0.25% bupivacaine .Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. |
| Oblique subcostal transversus abdomınıs plane block group | Active comparator | Procedure: unilateral oblique subcostal transversus abdomınıs plane block groupUnder general anaesthesia, Ultrasound guided unilateral oblique subcostal transversus abdomınıs plane block will perform with 20 ml of 0.25% bupivacaine. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours |
| Local anesthetic infiltration group | Active comparator | Procedure: Local anesthetic infiltration group4 trocars will be used by the surgical team during the operation, and these trocars will be placed 10 mm infraumbilical, 10 mm in the middle epigastrium, 5 cm below the xiphoid, 5 mm in the midclavicular line and in the right subcostal region, and 5 mm in the anterior axillary line. Before trocar placement, 0.25% bupivacaine will be applied to the skin, fascia, muscle and preperitoneal area in accordance with the infiltration rules. A total of 20 mL of 0.25% bupivacaine will be used, 6 mL for 10 mm trocar sites and 4 mL for 5 mm trocar sites. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours |
| Control Group | Sham comparator | Drug: Control groupAll patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) Patient controlled analgesia protocols were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65
- Patients undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists score 1-2 patients
- Body mass index ) <35kg/m2
- Patients whose consent was obtained before the procedure
Key exclusion criteria (14 listed)
- Patients under the age of 18 and over the age of 65
- American Society of Anesthesiologists score III and above
- Surgeries with an operating time exceeding 120 minutes
- Emergency surgeries
- Those who have had abdominal surgery
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 |
|---|---|---|
| unilateral external oblique intercostal plane block groupUSG guided external oblique intercostal plane block will perform unilateral with Bupivacaine 25 patient included and patients were observed for pain for 24 hours | Procedure or surgery | External oblique intercostal plane block group |
| unilateral oblique subcostal transversus abdomınıs plane block groupUSG guided oblique subcostal transversus abdomınıs plane block block will perform unilateral with Bupivacaine. 25 patient included and patients were observed for pain for 24 hours | Procedure or surgery | Oblique subcostal transversus abdomınıs plane block group |
| Local anesthetic infiltration groupBupivacaine infiltration will be performed to trocar insertion sites. 25 patient included and patients were observed for pain for 24 hours | Procedure or surgery | Local anesthetic infiltration group |
| Control groupAlso: intravenous patient controlled analgesia group with tramadolAll patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) patient controlled analgesias were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours | Drug | Control Group |
Primary outcome
Amount of postoperative opioid use
Time frame: 24 hours
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours
Finding out which method is more effective according to the Numerical Rating Scale (0-10)
Time frame: 24 hours
To find out which method provides more effective analgesia according to the Numeric Rating Scale patients followed for 24 hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain
2 secondary outcomes
postoperative nause and vomiting
Time frame: 24 hours
postoperative shoulder pain
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- 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.
Buğra Kurtoğlu, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral external oblique intercostal plane block group, unilateral oblique subcostal transversus abdomınıs plane block group and Local anesthetic infiltration group in people with Postoperative Pain and Regional Anesthesia, run by Ankara City Hospital Bilkent 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 5 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: status not confirmed, as of the sponsor's last update on 5 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Amount of postoperative opioid use (time frame: 24 hours). The study lists 2 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 5 Jun 2024.