NCT07830706

Brief Summary

This study evaluated whether bilateral erector spinae plane block (ESPB) performed before abdominal hysterectomy could reduce postoperative pain and the development of chronic and neuropathic pain. Adult patients undergoing abdominal hysterectomy under general anesthesia were assigned to receive either bilateral ESPB with bupivacaine or standard perioperative analgesic management without ESPB. Postoperative pain was assessed during the early postoperative period and at 1 and 6 months after surgery. Chronic and neuropathic pain were evaluated at 1 and 6 months using validated pain assessment tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 15, 2026

Last Update Submit

September 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chronic postoperative pain severity at 6 months

    Chronic postoperative pain severity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).

    6 months after surgery

Study Arms (2)

ESPB Group

EXPERIMENTAL

Participants assigned to the ESPB group received bilateral ultrasound-guided erector spinae plane block at the T8-T9 level before surgery, with 20 mL of 0.25% bupivacaine administered on each side, in addition to standard perioperative analgesic management.

Drug: Bupivacaine

Control Group

ACTIVE COMPARATOR

Participants assigned to the control group received standard perioperative analgesic management without erector spinae plane block.

Other: Standard Perioperative Analgesia

Interventions

0.25% bupivacaine, 20 mL administered bilaterally as part of ultrasound-guided erector spinae plane block at T8-T9.

ESPB Group

Participants received standard perioperative analgesic management according to the routine institutional protocol, without erector spinae plane block.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body mass index (BMI) \<35 kg/m²
  • Scheduled for elective total abdominal hysterectomy under general anesthesia
  • Provided informed consent to participate in the study

You may not qualify if:

  • Decompensated heart failure
  • Severe respiratory distress
  • Renal failure
  • Hepatic failure
  • History of opioid addiction
  • Current anticoagulant use or bleeding diathesis
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital Konya, Türkiye

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The postoperative outcomes assessor was blinded to group allocation. Participants, the anesthesiologist performing the intervention, and the care providers were not blinded because of the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations