NCT07260396

Brief Summary

Hysterectomy is one of the most common major gynecologic surgeries performed for various indications, and hundreds of thousands of procedures are carried out annually, particularly in developed countries. In total abdominal hysterectomies, the Pfannenstiel incision is frequently preferred due to its advantages in terms of aesthetics, functionality, and postoperative recovery. However, this incision can cause significant postoperative pain because of the extensive cutaneous innervation of the lower abdominal wall. This pain may delay early mobilization and negatively affect patient comfort and satisfaction. As part of multimodal analgesia strategies, regional anesthesia techniques are widely used in such surgeries to reduce opioid consumption and enhance analgesic efficacy. In this context, the Transversus Abdominis Plane (TAP) block and the Rectus Sheath Block (RSB) are among the effective techniques targeting the anterior abdominal wall, and various studies have investigated their spread patterns and clinical outcomes. However, data on the extent to which these blocks provide cutaneous sensory coverage of the Pfannenstiel incision remain limited, and direct comparative mapping studies are scarce in the literature. For patients undergoing hysterectomy, regional anesthesia techniques are commonly applied perioperatively either as a single technique or in combination for pain management, with TAP and RSB being the most frequently used modalities. In addition, patient-controlled analgesia (PCA) devices are routinely employed as a component of multimodal pain management in this population. The aim of this study is to comparatively evaluate the cutaneous sensory block areas produced by the TAP and RSB regional anesthesia techniques, their rates of coverage of the Pfannenstiel incision, and their clinical effectiveness.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026Jul 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

Regional AnesthesiaPostoperative PainCutaneous Sensory Mapping

Outcome Measures

Primary Outcomes (1)

  • Calculation of the coverage rates of the Pfannenstiel incision by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.

    45 minutes after block application

Secondary Outcomes (4)

  • Calculation of the coverage rates of the anterior abdomen by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.

    45 minutes after block application

  • Comparison of 24-hour morphine consumption between the two groups.

    First 24 postoperative hours

  • Comparison of Numerical Rating Scale (NRS) scores between the two groups.

    Postoperative 1, 3, 6, 12, 18, and 24. hours

  • Comparison of Quality of Recovery-15 (QoR-15) scores between the two groups.

    24 hours after surgery

Study Arms (2)

Group Transversus Abdominis Plane Block (TAPB)

Patients who received an ultrasound-guided bilateral Transversus Abdominis Plane Block during the preoperative period.

Procedure: Group Transversus Abdominis Plane Block

Group Rectus Sheath Block (RSB)

Patients who received an ultrasound-guided bilateral Rectus Sheath Block during the preoperative period.

Procedure: Group Rectus Sheath Block

Interventions

Patients will receive a bilateral rectus sheath block preoperatively under ultrasound guidance. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals.

Group Rectus Sheath Block (RSB)

Patients will receive a bilateral transversus abdominis plane block preoperatively under ultrasound guidance. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals.

Group Transversus Abdominis Plane Block (TAPB)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients undergoing total abdominal hysterectomy with a Pfannenstiel incision will be included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for total abdominal hysterectomy with a Pfannenstiel incision and receiving regional anesthesia as part of their perioperative analgesia management will be included in the study.

You may qualify if:

  • ASA physical status I-II-III
  • Patients scheduled for elective total abdominal hysterectomy under general anesthesia and who have received either a preoperative rectus sheath block or a transversus abdominis plane block
  • Aged 18-70 years
  • Patients who agree to participate in the study and provide written informed consent

You may not qualify if:

  • Patients who refuse to participate
  • Patients who have not received any regional anesthesia technique
  • ASA physical status IV
  • Patients in whom unilateral or bilateral sensory spread is not observed following the bilaterally applied regional anesthesia technique
  • Patients who are uncooperative or have cognitive impairment or dementia
  • Patients with psychiatric disorders such as depression, mania, or schizophrenia, or those using antipsychotic medications for more than 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Aoyama Y, Sakura S, Abe S, Wada M, Saito Y. Analgesic effects and distribution of cutaneous sensory blockade of quadratus lumborum block type 2 and posterior transversus abdominis plane block: an observational comparative study. Korean J Anesthesiol. 2020 Aug;73(4):326-333. doi: 10.4097/kja.19404. Epub 2020 Jan 31.

    PMID: 32008278BACKGROUND
  • Abuelghar WM, El-Bishry G, Emam LH. Caesarean deliveries by Pfannenstiel versus Joel-Cohen incision: A randomised controlled trial. J Turk Ger Gynecol Assoc. 2013 Dec 1;14(4):194-200. doi: 10.5152/jtgga.2013.75725. eCollection 2013.

    PMID: 24592105BACKGROUND
  • Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.

    PMID: 37642285BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • Sevda Akdeniz

    Samsun University

    STUDY DIRECTOR

Central Study Contacts

Busra Yilmaz, M.D.

CONTACT

Mert Yilmaz, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

December 3, 2025

Record last verified: 2025-11