Rhomboid Intercostal Block with Subserratus Plane Block in Bariatric Surgery

NCT06729515 | Completed DMC FDA Device

• 1 other identifier: 2022-MER-116
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Standard analgesic techniques such as patient-controlled analgesia (PCA) and continuous epidural analgesia (CEA) are effective but associated with considerable side effects, including nausea, hypotension, and respiratory depression. This study aimed to evaluate the efficacy and safety of the rhomboid intercostal block combined with subserratus plane block (RISS) compared to PCA and CEA for postoperative analgesia in bariatric surgery.

Conditions

Obesity/therapy

Keywords

patient-controlled analgesia; continuous epidural analgesia; the rhomboid intercostal block combined with subserratus plane block; bariatric surgery; numerical rating scale

Outcome Measures

Primary Outcomes (1)

• NRS

  The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.

  Postoperative 4th hour, postoperative 8th hour, postoperative 12th hour, postoperative 24th hour

Secondary Outcomes (1)

• Likert scale

  Postoperative 4th hour, postoperative 8th hour, postoperative 12th hour, postoperative 24th hour

Study Arms (3)

PCA group

ACTIVE COMPARATOR

patient-controlled analgesia

Device: PCA

CEA group

ACTIVE COMPARATOR

continuous epidural analgesia

Device: CEA

RISS group

EXPERIMENTAL

the rhomboid intercostal block combined with subserratus plane block

Device: RISS

Interventions

PCA DEVICE

Immediately post-surgery, patients in the PCA group received a programmed PCA infusion (YG-B-3; Jiangsu Yaguang Medical Device Co., Ltd., China) containing either ketorolac (180 mg) or sufentanil (200 µg) in 100 mL, delivered as a 2 mL/h basal infusion with 0.5 mL boluses; lockout interval: 15 min.

PCA group

CEA DEVICE

Following epidural catheter placement in the operating room, the CEA group received an initial bolus of 2% lidocaine (3 mL). Once sensory blockade was confirmed, continuous epidural infusion of 0.1% ropivacaine (8 mL/h) commenced.

CEA group

RISS DEVICE

RISS blocks were performed at the T4-T10 level under ultrasound guidance (EPIQ5 with L12-4 linear 7.5 MHz transducer; Philips Healthcare, Best, Netherlands). A 19-gauge, 40-cm catheter was advanced 3-5 cm beyond the needle tip into the subserratus plane, its position confirmed by injecting 5 mL of 0.2% ropivacaine. A further 15 mL of 0.2% ropivacaine was then administered. The catheter was connected to a PCA pump programmed to deliver a 7 mL/h basal infusion with 2 mL boluses; lockout interval: 30 min.

RISS group

Eligibility Criteria

• Age: 20 Years - 41 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 20-41 years
• ASA I-III
• body mass index (BMI) ≥27.5 kg/m² or BMI \<27.5 kg/m² with obesity-related comorbidities (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, or non-alcoholic fatty liver disease)
• failure to achieve significant weight loss with conservative management (diet and/or pharmacotherapy)
• the capacity for postoperative care and lifestyle modification

You may not qualify if:

• severe cardiopulmonary or hepatic disease
• untreated major psychiatric disorders or active substance abuse potentially affecting postoperative lifestyle management; pregnancy or intention to conceive
• inability to complete long-term follow-up or lifestyle adjustments; or inability to obtain complete trial data
• Patients who refused to provide written informed consent were excluded

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research

Model Details: PCA group Immediately post-surgery, patients in the PCA group received a programmed PCA infusion (YG-B-3; Jiangsu Yaguang Medical Device Co., Ltd., China) containing either ketorolac (180 mg) or sufentanil (200 µg) in 100 mL, delivered as a 2 mL/h basal infusion with 0.5 mL boluses; lockout interval: 15 min. CEA group Following epidural catheter placement in the operating room, the CEA group received an initial bolus of 2% lidocaine (3 mL). Once sensory blockade was confirmed, continuous epidural infusion of 0.1% ropivacaine (8 mL/h) commenced. RISS group RISS blocks were performed at the T4-T10 level under ultrasound guidance (EPIQ5 with L12-4 linear 7.5 MHz transducer; Philips Healthcare, Best, Netherlands). A 19-gauge, 40-cm catheter was advanced 3-5 cm beyond the needle tip into the subserratus plane, its position confirmed by injecting 5 mL of 0.2% ropivacaine. A further 15 mL of 0.2% ropivacaine was then administered. The catheter was connected to a PCA pump programmed to deliver

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: January 2025-January 2026
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)