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Comparison of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Cholecystectomy, Cholelithiasis, Postoperative Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
unilateral ultrasound-guided oblique subcostal TAP block with %0.9 NaCl 30ml
unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
unilateral ultrasound-guided posterior TAP block with %0.9 NaCl 30ml
Sponsored by
Ceylan Saygili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Cholecystectomy focused on measuring Transversus Abdominis Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective laparoscopic cholecystectomy for cholelithiasis
  • ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

  • Patient refusal
  • Perforation of the gallbladder
  • Patients with acute cholecystitis
  • History of the previous gallbladder surgery
  • Pregnancy
  • Morbid obesity
  • Psychiatric disorder
  • Epilepsia
  • Renal insufficiency
  • Coagulopathy
  • Patients known allergic to drugs used for study

Sites / Locations

  • Cerrahpasa Medical Faculty General Surgery Operating Theater

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

oblique subcostal tap block

posterior tap block

dual tap block

Arm Description

ultrasound-guided right oblique subcostal TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl (sodium chloride) 10ml and ultrasound-guided posterior TAP block with %0.9 NaCl 30ml

ultrasound-guided right oblique subcostal TAP block with %0.9 NaCl 30ml and ultrasound-guided posterior TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml

ultrasound-guided right oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml and ultrasound-guided posterior TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml

Outcomes

Primary Outcome Measures

postoperative pain intensity at rest and with motion
postoperative 0th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is awake in postanesthesia care unit. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 2nd hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 4th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 6th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 8th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 12th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
postoperative pain intensity at rest and with motion
postoperative 24th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.

Secondary Outcome Measures

postoperative opioid consumption
opioids given at post-anaesthesia care unit and ward
postoperative dermatomal level of sensory block
postoperative 0.,2.,4.,6.,8.,12. and 24.hours via pinprick test
postoperative sedation
postoperative 0.,2.,4.,6.,8.,12. and 24.hours Ramsey Sedation Scale; (1) anxious and agitated or restless or both; (2) co-operative, oriented and tranquil; (3) responding to commands only; (4) brisk response to light glabellar tap or loud auditory stimulus; (5) sluggish response to light glabellar tap or loud auditory stimulus; (6) no response to stimulus.
postoperative nausea and vomiting
postoperative 0.,2.,4.,6.,8.,12. and 24.hours Nausea and Vomiting Score; (0) without nausea or vomiting; (1) nausea without vomiting; (2) one episode of vomiting; (3) two or more episode of vomiting

Full Information

First Posted
December 25, 2020
Last Updated
May 30, 2023
Sponsor
Ceylan Saygili
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04693156
Brief Title
Comparison of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Official Title
Comparison of the Analgesic Effects of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane (TAP) Block in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ceylan Saygili
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the difference of postoperative analgesic effects and opioid consumption between ultrasound-guided unilateral oblique subcostal, posterior, or dual TAP blocks in patients undergoing laparoscopic cholecystectomy for cholelithiasis.
Detailed Description
Laparoscopic cholecystectomy is one of the most frequent operations. Laparoscopic cholecystectomy is a less invasive technic that provides early mobilization and reduces hospitalization time thus preferred to laparotomy often. There is a minimum of 4 trochar incisions on the right side of the abdomen at epigastric, umbilical, midclavicular subcostal, and anterior axillary subcostal regions in laparoscopic cholecystectomy. Some patients have a drainage tube at the middle/lower right abdomen. Thus the right side of the abdomen is the target side for abdominal wall blocks. Most patients complain of moderate pain after surgery which requiring opioids, mostly in the upper abdomen, lower abdomen, and shoulder. The pain has three components; somatic pain at the anterior abdominal wall, visceral pain caused by pneumoperitoneum and referred shoulder pain. Preventing postoperative pain is important for reducing respiratory complications and hospitalization time also improve patient satisfaction. Opioids are preferred less due to their side effects like nausea-vomiting and respiratory depression although which is preferable for moderate and severe pain. Transversus abdominis plane (TAP) block is the most preferred abdominal wall block to provide effective postoperative pain control for reducing perioperative analgesic requirements like opioids. TAP block was first described by Rafi by anatomic landmark technic then by Hebbard with ultrasonographic guidance. TAP block is a regional technic and a plan block that blocks the thoracolumbar nerves that innervate the anterior and lateral abdominal wall and passes in between the muscles' internal oblique and transversus abdominis. External oblique, internal oblique, and transversus abdominis muscles are displayed sequentially by ultrasonography. A hypoechoic, spindle-shaped separation of the fascia by hydrodissection technic is performed by local anesthetic injection in between the internal oblique muscle (or rectus abdominis) and transversus abdominis muscle. Dermatomal spread is differentiated with subcostal, oblique subcostal, and posterior approaches. In oblique subcostal TAP block, anesthetic solution spreads across the location of T6-L1 nerves thus suitable for surgeries at both superior and inferior the umbilicus. Some other studies show that posterior TAP block can block the T5 to L1 thoracolumbar nerves thereby spreading into paravertebral space. The paravertebral spread of the posterior TAP block suggests that the analgesic efficacy will be long-lasting by blocking the thoracolumbar sympathetic chain and will spread to a wider dermatomal area. In this study, the investigators aimed to compare the analgesic efficacy and opioid-sparing effects of oblique subcostal, posterior, and dual TAP blocks in patients undergoing laparoscopic cholecystectomy. Taking the advantage of the paravertebral extension of the posterior approach and the wide spread of the oblique subcostal approach on the anterior abdominal wall, it's supposed to be the dual TAP block will result in lower pain scores. All patients will have general anesthesia. For premedication midazolam 0.03mg/kg will be used for all patients. At the induction of the anesthesia, patients will receive propofol 2 mg/ kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/ kg IV. After enough muscle relaxation patients will be orotracheally intubated. General anesthesia will be maintained with sevoflurane and air/O2 mixture. The end-tidal carbon dioxide partial pressure will be maintained between 32 and 36 mmHg by adjusting the pressure-controlled mechanical ventilation. All patients will receive tramadol 1mg/kg, paracetamol 1gr, and ondansetron 8mg intravenously before skin closure. Postoperatively ultrasound-guided right oblique subcostal and posterior TAP blocks will be performed on all patients. Postoperatively starting from at the postoperative care unit (0th hour) then 2nd,4th, 6th, 8th, 12th and 24th hours pain intensity by numerical rating scale (NRS) at rest and with motion, sensory dermatomal involvement by pinprick test, Ramsey sedation scales, nausea and vomiting scores, and rescue analgesic medication requirements will be recorded. Besides heart rate, blood pressure, respiratory rate, peripheric oxygen saturation, mobilization time, side effects if there are any will be recorded at the aforementioned hours. Patients with NRS≥4 will receive dexketoprofen 50mg as rescue analgesic medication. If NRS≥7 tramadol 100mg will be administered. The study will start after getting written informed consent from patients who are informed about the study and potential risks. The study is a prospective, clinical, randomized controlled, quadruple-blinded, and monocenter study. Participation of the 60 patients undergoing laparoscopic cholecystectomy had been planned. Patients will be randomized into three groups of 20 patients each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Cholelithiasis, Postoperative Analgesia
Keywords
Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oblique subcostal tap block
Arm Type
Active Comparator
Arm Description
ultrasound-guided right oblique subcostal TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl (sodium chloride) 10ml and ultrasound-guided posterior TAP block with %0.9 NaCl 30ml
Arm Title
posterior tap block
Arm Type
Active Comparator
Arm Description
ultrasound-guided right oblique subcostal TAP block with %0.9 NaCl 30ml and ultrasound-guided posterior TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
Arm Title
dual tap block
Arm Type
Active Comparator
Arm Description
ultrasound-guided right oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml and ultrasound-guided posterior TAP block with an anesthetic solution of %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
Intervention Type
Procedure
Intervention Name(s)
unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
Intervention Description
In the supine position, after the skin sterilization, ultrasound with a high-frequency linear probe will be placed subcostally and from the xiphoid to the right iliac crest obliquely. The rectus abdominis and underlying transversus abdominis muscles will be identified. The local anesthetic solution (%0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml) will be injected after negative aspiration to the transversus abdominis plane between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line.
Intervention Type
Procedure
Intervention Name(s)
unilateral ultrasound-guided oblique subcostal TAP block with %0.9 NaCl 30ml
Intervention Description
In the supine position, after the skin sterilization, ultrasound with a high-frequency linear probe will be placed subcostally and from the xiphoid to the right iliac crest obliquely. %0.9 NaCl 30ml will be injected after negative aspiration to the transversus abdominis plane between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line.
Intervention Type
Procedure
Intervention Name(s)
unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml
Intervention Description
After the oblique subcostal TAP block, the operation table will be slightly turned left laterally for better visualization of the blocking area. The same high-frequency linear ultrasound (Esaote MyLab5) probe will be placed over the postero-lateral abdominal wall, posterior of the mid-axillary line between the costal margin and iliac crest. After the identification of the internal abdominis, transversus abdominis, and quadratus lumborum muscles, the needle will be advanced into the transversus abdominis plane between the internal abdominis and transversus abdominis muscles, at the aponeurosis of quadratus lumborum and these muscles. The local anesthetic solution (%0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml) will be injected after negative aspiration.
Intervention Type
Procedure
Intervention Name(s)
unilateral ultrasound-guided posterior TAP block with %0.9 NaCl 30ml
Intervention Description
After the oblique subcostal TAP block, the operation table will be slightly turned left laterally for better visualization of the blocking area. The same high-frequency linear ultrasound probe will be placed over the postero-lateral abdominal wall, posterior of the mid-axillary line between the costal margin and iliac crest. After the identification of the internal abdominis, transversus abdominis, and quadratus lumborum muscles, the needle will be advanced into the transversus abdominis plane between the internal abdominis and transversus abdominis muscles, at the aponeurosis of quadratus lumborum and these muscles. %0.9 NaCl 30ml will be injected after negative aspiration.
Primary Outcome Measure Information:
Title
postoperative pain intensity at rest and with motion
Description
postoperative 0th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is awake in postanesthesia care unit. This outcome is compared between all three groups.
Time Frame
postoperative 0 hour
Title
postoperative pain intensity at rest and with motion
Description
postoperative 2nd hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 2 hours
Title
postoperative pain intensity at rest and with motion
Description
postoperative 4th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 4 hours
Title
postoperative pain intensity at rest and with motion
Description
postoperative 6th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 6 hours
Title
postoperative pain intensity at rest and with motion
Description
postoperative 8th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 8 hours
Title
postoperative pain intensity at rest and with motion
Description
postoperative 12th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 12 hours
Title
postoperative pain intensity at rest and with motion
Description
postoperative 24th hour Numerical Rating Scale measured on 0-10 ( 0= no pain, 10= the worst imaginable pain) when patient is on the ward. This outcome is compared between all three groups.
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
postoperative opioid consumption
Description
opioids given at post-anaesthesia care unit and ward
Time Frame
24 hours
Title
postoperative dermatomal level of sensory block
Description
postoperative 0.,2.,4.,6.,8.,12. and 24.hours via pinprick test
Time Frame
24 hours
Title
postoperative sedation
Description
postoperative 0.,2.,4.,6.,8.,12. and 24.hours Ramsey Sedation Scale; (1) anxious and agitated or restless or both; (2) co-operative, oriented and tranquil; (3) responding to commands only; (4) brisk response to light glabellar tap or loud auditory stimulus; (5) sluggish response to light glabellar tap or loud auditory stimulus; (6) no response to stimulus.
Time Frame
24 hours
Title
postoperative nausea and vomiting
Description
postoperative 0.,2.,4.,6.,8.,12. and 24.hours Nausea and Vomiting Score; (0) without nausea or vomiting; (1) nausea without vomiting; (2) one episode of vomiting; (3) two or more episode of vomiting
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective laparoscopic cholecystectomy for cholelithiasis ASA (American Society of Anesthesiologists) I-II Exclusion Criteria: Patient refusal Perforation of the gallbladder Patients with acute cholecystitis History of the previous gallbladder surgery Pregnancy Morbid obesity Psychiatric disorder Epilepsia Renal insufficiency Coagulopathy Patients known allergic to drugs used for study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatis Altındas, Prof. Dr.
Organizational Affiliation
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emre S Erbabacan, Asc.Prof
Organizational Affiliation
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aylin Ozdilek, Asc.Prof
Organizational Affiliation
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cigdem Akyol Beyoglu, M.D.
Organizational Affiliation
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ceylan Saygili, M.D.
Organizational Affiliation
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cerrahpasa Medical Faculty General Surgery Operating Theater
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD (individual participant data) available to other researchers
Citations:
PubMed Identifier
8165491
Citation
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Citation
Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
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Citation
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Comparison of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

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