NCT07113600

Brief Summary

The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia. One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block). The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ). Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

July 22, 2025

Last Update Submit

August 2, 2025

Conditions

Keywords

HumansFemaleAnesthesia, ConductionUltrasonographyNerve BlockPain, PostoperativeUltrasonography, Interventional

Outcome Measures

Primary Outcomes (1)

  • The time to first call for analgesia.

    The period of time starting from extubation until the patient asks for analgesia in hours.

    The first 12 postoperative hours

Secondary Outcomes (2)

  • postoperative pain score

    VAS was assessed at 0, 2, 6, and 12 hours postoperatively.

  • intraoperative hemodynamic changes

    Operative time

Other Outcomes (1)

  • Total post-operative opioid consumption

    The first 12 postoperative hours

Study Arms (2)

ESPB

ACTIVE COMPARATOR

Patients will receive bilateral Erector Spinae Plane block using 20ml bupivacaine 0.25% on each side.

Other: Nerve Block

Ilioinguinal/iliohypogastric

ACTIVE COMPARATOR

Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20ml bupivacaine 0.25% on each side.

Other: Nerve Block

Interventions

Ilioinguinal/ Iliohypogastric nerve block: In the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane. A echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is injected gradually close to the nerves. Erector spinae plane block: In a lateral position, the erector spinae is visualized about 3 cm lateral to T7-T9 spinous processes on the target side. A echogenic needle (50 mm/22 gauge) is advanced in a cephalad to caudad direction until the tip reaches the plane deep to the erector spinae muscle immediately lateral to the transverse process. A 20 ml bupivacaine 0.25% is injected gradually into this plane.

ESPBIlioinguinal/iliohypogastric

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult female patients above the age of 35 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.

You may not qualify if:

  • Patient refusal.
  • History of allergy or intolerance to study medications.
  • Chronic opioid use (\>3 months).
  • Severe renal or hepatic impairment.
  • Patients with coagulopathy disorders.
  • Infection at injection sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both blocks will be performed after induction of general anesthesia
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly allocated with a 1:1 allocation ratio into two groups in a parallel manner: * Group A(n=29): Patients will receive bilateral ESP block using 20 ml bupivacaine 0.25% on each side. * Group B(n=29): Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20 ml bupivacaine 0.25% on each side.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Of anesthesia

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 11, 2025

Study Start

August 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08