Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy

NCT06768385 | Completed

• 1 other identifier: SBU-ANESTHESİA-DMY-02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

In laparoscopic cholecystectomies, ultrasound-guided interfascial plane blocks are commonly used for postoperative analgesia. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerve block with the perichondral approach (TAPA) with transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy.

Conditions

Pain, Postoperative

Keywords

laparoscopic cholecystectomy; transversus abdominis plane block; thoracoabdominal nerve block with the perichondral approach

Outcome Measures

Primary Outcomes (1)

• postoperative analgesic efficacy

  NRS (Numerical Rating Scale) was used for pain monitoring. Patients were informed about the NRS assessment for pain. It was stated that a score of 0 meant no pain and a score of 10 meant the worst pain imaginable. After the first assessment hour when NRS \>4 was noted in patients, IV analgesia treatment was started (dexketoprofen 50 mg IV as additional analgesic). If NRS \<4 and the patient did not request analgesic, the drug dose was skipped.

  At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.

Secondary Outcomes (1)

• presence of nausea-vomiting

  the postoperative 2nd, 6th, 12th and 24th hours

Study Arms (2)

group T

ACTIVE COMPARATOR

After general anesthesia induction, TAP block was applied to Group T. TAP block is the application of local anaesthetic agents to the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen.

Procedure: Transversus abdominis plane (TAP) block

group P

ACTIVE COMPARATOR

TAPA block was applied to Group P. In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium.

Procedure: thoracoabdominal nerve blockage with perichondrial approach (TAPA) block

Interventions

Transversus abdominis plane (TAP) block PROCEDURE

: It was performed under USG guidance using 30 ml of 0.25% bupivacaine with an 80 mm insulated peripheral block needle. Local anaesthetic was applied between the upper fascia of the transversus abdominus muscle and the fascia of the internal oblique muscle at the midpoint of the distance between the costal margin and the iliac crest in the midaxillary line under USG imaging guidance.

group T

thoracoabdominal nerve blockage with perichondrial approach (TAPA) block PROCEDURE

Under USG guidance, 20 ml of 0.25% bupivacaine was administered between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue at the level of the 9th and 10th ribs (arcus costarum) in the midclavicular line with an 80 mm insulated peripheral block needle. Then, 10 ml of 0.25% bupivacaine was injected into the upper fascia of the costochondral tissue and the lower fascia of the external oblique muscle. The block was performed by following the needle path in the ultrasound image.

group P

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

SBU Sultan Abdulhamid Han

Istanbul, Asia, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion; tapasin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Dilek M Yamac

  Sultan Abdülhamid Han education and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study was conducted using a sealed envelope system. The sealed, opaque, sequentially numbered envelopes were opened by intervention staff who conducted induction of anesthesia and block procedure just prior to surgery. A second investigator involved in the assessment of postoperative outcomes and another investigator involved in data collection were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The patients were randomly allocated to one of two groups using a computer-generated randomized sequence table with an allocation ratio of 1:1 and a block size of two.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)