USG-guided M-TAPA vs OSTAP Block in Patients Undergoing Laparoscopic Cholecystectomy

NCT05108129 | Completed

• 1 other identifier: 07-2021/02
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the postoperative analgesic effect of ultrasound-guided modified thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and oblique subcostal transversus abdominis plane block(OSTAP) will be searched in patients recruiting for laparoscopic cholecystectomy (LC) and the two groups will be compared in terms postoperative opioid consumption. The primary aim of this study is to compare the effects of ultrasound-guided (M-TAPA) and OSTAP blocks on opioid consumption after LC surgery. It is hypothesized that M-TAPA will reduce opioid consumption of the patients more than the OSTAP block.

Conditions

Laparoscopic Cholecystectomy

Keywords

modified-thoracoabdominal nerves block; oblique subcostal transversus abdominis plane block; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total daily consumption of rescue analgesic

  If Numerical Rating Scale (NRS) score of the patient is equal to or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

  Postoperative 24 hours

Secondary Outcomes (7)

• Numerical Rating Scale scores

  Postoperative 24 hours

• Time to first rescue analgesic

  Postoperative 24 hours

• Adverse events

  Postoperative 24 hour

• Metoclopromide consumption

  Postoperative 24 hour

• Sedation score

  Postoperative 24 hour

Study Arms (2)

Group M-TAPA

ACTIVE COMPARATOR

In the operating room, all of the patients will receive standard monitoring. An anesthesiologist will perform anesthesia inductions. After tracheal intubation, a linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 25 ml 0.25% bupivacaine will be injected between the transversus abdominis muscle and the lower aspect of the costal cartilage. The same procedure will be repeated on the contralateral side. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, dexketoprofen, and tramadol.

Procedure: M-TAPA block

Group OSTAP

EXPERIMENTAL

In the second group, the patients will receive oblique subcostal TAP block in the supine position immediately after the endotracheal intubation. The anesthesiologist of the operating room will place the ultrasound with a linear probe subcostally and from the xiphoid to the right iliac crest obliquely. Rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin. The needle will be directed to the transversus abdominis fascia. Local anesthetic solution of 25 ml 0.25% will be injected to between rectus abdominis and transversus abdominis muscles along the oblique subcostal line. The same procedure will repeated to the contralateral side. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, dexketoprofen, and tramadol.

Procedure: OSTAP block

Interventions

M-TAPA block PROCEDURE

After tracheal intubation, a high-frequency linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 25 ml 0.25% bupivacaine will be injected between the transversus abdominis muscle and the lower aspect of the costal cartilage. The same procedure will be repeated on the contralateral side. Standard perioperative and postoperative multimodal analgesia The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, dexketoprofen, and tramadol.

Also known as: Global Quality of Recovery-15 score, Standard Pain Follow up and Monitorization

Group M-TAPA

OSTAP block PROCEDURE

The patients will receive oblique subcostal TAP block in the supine position immediately after the endotracheal intubation. The anesthesiologist of the operating room will place the ultrasound with a linear probe subcostally and from the xiphoid to the right iliac crest obliquely. Rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin. The needle will be directed to the transversus abdominis fascia. Local anesthetic solution of 25 ml 0.25% will be injected to between rectus abdominis and transversus abdominis muscles along the oblique subcostal line. The same procedure will repeated to the contralateral side. Standard perioperative and postoperative multimodal analgesia The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, dexketoprofen, and tramadol.

Also known as: Global Quality of Recovery-15 score, Standard Pain Follow up and Monitorization

Group OSTAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

You may not qualify if:

• presence of coagulation disorder
• infection at the injection site of the block
• known allergy to local anesthetics
• advanced hepatic or renal failure
• can not communicate in Turkish
• history of abdominal surgery or trauma
• conversion of laparoscopic to open surgery
• consumption of any pain killers within the 24 h before the operation
• chronic opioid consumption
• pregnancy
• alcohol or drug abuse
• body mass index (BMI) ≥ 35 kg m-2.

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Bilge A, Basaran B, Altiparmak B, Et T, Korkusuz M, Yarimoglu R. Comparing ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach with oblique subcostal transversus abdominis plane block for patients undergoing laparoscopic cholecystectomy: a randomized, controlled trial. BMC Anesthesiol. 2023 Apr 27;23(1):139. doi: 10.1186/s12871-023-02106-z.

  PMID: 37106319 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Betul Basaran, MD,DESA

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blocks will be administered after induction of general Anesthesia so participants will be blinded to which intervention they have had. Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 4, 2021
• Study Start: November 11, 2021
• Primary Completion: March 23, 2022
• Study Completion: March 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2021-10

Locations

TU (1)