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

NCT04693156 | Completed

• 1 other identifier: 132002
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy; Cholelithiasis; Postoperative Analgesia

Keywords

Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (7)

• 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 0 hour

• 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 2 hours

• 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 4 hours

• 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 6 hours

• 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 8 hours

• 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 12 hours

• 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.

  postoperative 24 hours

Secondary Outcomes (4)

• postoperative opioid consumption

  24 hours

• postoperative dermatomal level of sensory block

  24 hours

• postoperative sedation

  24 hours

• postoperative nausea and vomiting

  24 hours

Study Arms (3)

oblique subcostal tap block

ACTIVE COMPARATOR

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

Procedure: unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml; Procedure: unilateral ultrasound-guided posterior TAP block with %0.9 NaCl 30ml

posterior tap block

ACTIVE COMPARATOR

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

Procedure: unilateral ultrasound-guided oblique subcostal TAP block with %0.9 NaCl 30ml; Procedure: unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml

dual tap block

ACTIVE COMPARATOR

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

Procedure: unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml; Procedure: unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml

Interventions

unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml PROCEDURE

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.

dual tap block; oblique subcostal tap block

unilateral ultrasound-guided oblique subcostal TAP block with %0.9 NaCl 30ml PROCEDURE

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.

posterior tap block

unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml PROCEDURE

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.

dual tap block; posterior tap block

unilateral ultrasound-guided posterior TAP block with %0.9 NaCl 30ml PROCEDURE

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.

oblique subcostal tap block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceylan Saygili: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Cerrahpasa Medical Faculty General Surgery Operating Theater

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (13)

• Ure BM, Troidl H, Spangenberger W, Dietrich A, Lefering R, Neugebauer E. Pain after laparoscopic cholecystectomy. Intensity and localization of pain and analysis of predictors in preoperative symptoms and intraoperative events. Surg Endosc. 1994 Feb;8(2):90-6. doi: 10.1007/BF00316616.

  PMID: 8165491 BACKGROUND

• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

  PMID: 9389858 BACKGROUND

• 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.

  PMID: 10718794 BACKGROUND

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 BACKGROUND

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 BACKGROUND

• Jankovic Z, Ahmad N, Ravishankar N, Archer F. Transversus abdominis plane block: how safe is it? Anesth Analg. 2008 Nov;107(5):1758-9. doi: 10.1213/ane.0b013e3181853619. No abstract available.

  PMID: 18931248 BACKGROUND

• Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

  PMID: 20830871 BACKGROUND

• Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

  PMID: 21851346 BACKGROUND

• Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.

  PMID: 23811424 BACKGROUND

• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

  PMID: 17961838 BACKGROUND

• Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.

  PMID: 24882606 BACKGROUND

• Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.

  PMID: 10352653 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fatis Altındas, Prof. Dr.

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation

  STUDY DIRECTOR

• Emre S Erbabacan, Asc.Prof

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation

  STUDY CHAIR

• Aylin Ozdilek, Asc.Prof

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation

  STUDY CHAIR

• Cigdem Akyol Beyoglu, M.D.

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation

  STUDY CHAIR

• Ceylan Saygili, M.D.

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 5, 2021
• Study Start: February 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)