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CompletedNCT06729515Updated Dec 11, 2024

Rhomboid Intercostal Block with Subserratus Plane Block in Bariatric Surgery

An interventional study of PCA and CEA in Obesity/therapy, sponsored by Xiaguang Duan. Completed at 1 site in China. Open to participants aged 20 Years to 41 Years. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by Xiaguang Duan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
20 Years to 41 Years
Sex
All
01

Study 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.

Read the detailed description

This prospective, randomized, double-blind, non-inferiority and superiority trial compared PCA, CEA, and RISS blocks for postoperative analgesia in bariatric surgery patients recruited at Baogang Hospital, Inner Mongolia. The study, approved by the Baogang Hospital Medical Ethics Committee (2022-MER-116; October 16, 2022), adhered to the Declaration of Helsinki and CONSORT guidelines. All participants provided informed consent.

This study included 144 patients (January-December 2023) undergoing elective bariatric surgery at Baogang Hospital, Inner Mongolia.

Patients were randomly assigned (1:1:1) to one of three groups: (1) PCA, (2) CEA, and (3) RISS block. Randomization was performed using a sequentially numbered, concealed allocation sequence generated from a random number table.

General anesthesia was induced with propofol (1.5-2 mg/kg i.v.), rocuronium (1-2 mg/kg i.v.), and fentanyl (1-2 µg/kg i.v.), followed by endotracheal intubation. Anesthesia was maintained with sevoflurane or desflurane, titrated to maintain a bispectral index (BIS) target. Remifentanil (0.05-0.2 µg/kg/min) was infused to maintain mean arterial pressure and heart rate within ±20% of baseline values. Mechanical ventilation was initiated using pressure-regulated volume control (PRVC) mode (Aestiva; GE Healthcare, Waukesha, WI, USA) with tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cm H₂O, inspiratory-expiratory ratio 1:2, respiratory rate 16 breaths per minute, and inspired oxygen fraction 0.41. The patient was positioned in a reverse Trendelenburg position (20-25° head-up tilt) and pneumoperitoneum was established with carbon dioxide at 10-15 mmHg.

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 a 7 mL/h basal infusion with 2 mL boluses; lockout interval: 30 min.

In the postanesthesia care unit (PACU), arterial blood pressure, heart rate, and the incidence of postoperative nausea and vomiting (PONV) were monitored and recorded. Symptomatic treatment was administered for hypotension, bradycardia, and PONV as needed.

Primary outcomes were rest and dynamic pain scores (numerical rating scale [NRS] ) at 4, 8, 12, and 24 hours postoperatively. Secondary outcomes included cumulative morphine equivalent dose (mg i.v.) at 4, 8, 12, and 24 hours postoperatively; incidence of postoperative nausea and vomiting (PONV); ondansetron use (mg); and quality of sleep on the first postoperative night (Likert scale, 1-5). Superiority and non-inferiority analyses were performed for all outcomes.

02

Conditions studied

  • Obesity/therapy

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Keywords

  • patient-controlled analgesia
  • continuous epidural analgesia
  • the rhomboid intercostal block combined with subserratus plane block
  • bariatric surgery
  • numerical rating scale
03

In context

Obesity

6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 114 is above the median of 77 across 5,091 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Xiaguang Duan is the lead sponsor of 11 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 41 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
114 participants (actual)

Study arms

  • Active comparator
    PCA group

    patient-controlled analgesia

    Device: PCA

  • Active comparator
    CEA group

    continuous epidural analgesia

    Device: CEA

  • Experimental
    RISS group

    the rhomboid intercostal block combined with subserratus plane block

    Device: RISS

Interventions

  • DevicePCA

    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.

  • DeviceCEA

    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.

  • DeviceRISS

    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.

06

What researchers measure

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.

    Time frame: Postoperative 4th hour, postoperative 8th hour, postoperative 12th hour, postoperative 24th hour

Secondary outcomes

  1. Likert scale

    quality of sleep on the first postoperative night (Likert scale, 1-5). Likert scale where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied and 5=very satisfied.

    Time frame: Postoperative 4th hour, postoperative 8th hour, postoperative 12th hour, postoperative 24th hour

07

Study locations

1 site
  • Inner Mongolia Baogang Hospital
    Baotou, Inner Mongolia 014010, China
08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06729515
Lead sponsor
Xiaguang Duan
Responsible party
Xiaguang Duan (Head of Research, Inner Mongolia Baogang Hospital) — Sponsor-investigator
First posted
Dec 11, 2024
Start date
Jan 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Dec 11, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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