CClinicalTrials.gg
RecruitingNCT05661279Updated Sep 6, 2023

Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

An interventional study of general anesthesia and general anesthesia plus Rhomboid intercostal block in Postoperative Pain, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study summary

evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

Read the detailed description
  • To assess and compare quality of post- operative analgesia in each group.
  • Time of performance of block in both groups.
  • To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.
02

Conditions studied

  • Postoperative Pain

Browse trials for

Keywords

  • rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 84 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients aged between 21 to 60 years
  • Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
  • Informed consents
  • ASA I \& II
  • Body mass index 25-30 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • patients on anti-platelet, anticoagulant or B blocker drugs
  • Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
  • history of allergy to local anesthesia or opioid analgesia,
  • pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    Group C:

    control group who will be given general anesthesia only

    Procedure: general anesthesia

  • Active comparator
    Group R:

    Rhomboid intercostal block then general anesthesia

    Procedure: general anesthesia · Procedure: general anesthesia plus Rhomboid intercostal block

  • Active comparator
    group S

    Serratus anterior plane block then general anesthesia

    Procedure: general anesthesia · Procedure: Serratus anterior plane block

Interventions

  • Proceduregeneral anesthesia

    general anesthesia

  • Proceduregeneral anesthesia plus Rhomboid intercostal block

    the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia

  • ProcedureSerratus anterior plane block

    The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia

06

What researchers measure

Primary outcomes

  1. tramadol consumption

    The amount of tramadol consumption

    Time frame: at 24 hours postoperative

Secondary outcomes

  1. Time of performance of block

    Time needed to performance the block

    Time frame: time from positioning of ultrasound porbe till the end of block procedure.

  2. Time to first dose of rescue analgesia

    the first time that the patients need analgesia when VAS ≥ 3

    Time frame: during the first 24 hours postoperatively

  3. Anticipated side effect

    nausea, vomiting, local anesthesia toxicity, needle injury

    Time frame: at 24 hous post operative

  4. Post operative patient's satisfaction

    Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)

    Time frame: at 24 hours post operative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

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 Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05661279
Lead sponsor
Zagazig University
Responsible party
Heba M Fathi (prof/Dr, Zagazig University) — Principal investigator
First posted
Dec 22, 2022
Start date
Dec 30, 2022
Primary completion
Oct 2, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Sep 6, 2023

Study contacts

Heba M Fathi, M.D
Contact
heba_elgendi@yahoo.com
01000143938
Heba M Fathi
principal investigator · faculty of human medicine ,zagazig university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion