NCT07051499

Brief Summary

Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 21, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 13, 2025

Last Update Submit

June 25, 2025

Conditions

Postoperative Pain

Keywords

Gynecologic surgeryPain managementTAP BlockRegional AnesthesiaIntravenous AnalgesiaERAS

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity (Numeric Rating Scale)

    Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively.

    1, 6, 24 hours postoperatively.

Secondary Outcomes (3)

  • Total Analgesic Consuption.

    0-24 hours postoperatively.

  • Incidence of Side Effects.

    0-24 hours postoperatively

  • Patient Satisfaction With Analgesia

    24 hours postoperatively

Study Arms (2)

tap block group

\- TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).

intravenous analgesia

Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.

Drug: TAP Block Group

Interventions

TAP Block GroupDRUG

Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).

intravenous analgesia

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall consecutive women undergoing gynecological surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery).

You may qualify if:

  • age \> 18 years, scheduled for elective gynecological surgery

You may not qualify if:

  • age \<18, emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico di Foggia

Foggia, Apulia, 71122, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
20 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 13, 2025

First Posted

July 4, 2025

Study Start

January 21, 2025

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

July 4, 2025

Record last verified: 2025-06

Locations

IT(1)