Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy

NCT ID: NCT07178262

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-30

Brief Summary

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Hystrectomy is a surgical procedure that involves removal of uterus from the body of patient using a lower abdominal incision. This is an extremely painful procedure which causes discomfort and greatly increases opioids consumption in the peri-operative period. This can be reduced by using nerve blocks such as Erector spinae plane block.

Detailed Description

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Total abdominal hystrectomy is associated with significant pain due to large abdominal incision and significant surgical dissection. This greatly increases the consumption of Opioid in the peri-operative period. High dose opioid consumption is associated with constipation, nausea, vomiting and respiratory depression. This significantly hampers post operative recovery. Fascial plane blocks such as Erector spinae block provides significant analgesia greatly reducing opioid consumption and there by reducing the associated side effects.

Conditions

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Erector Spinae Block Enhanced Recovery After Surgery (ERAS) Protocol Opioid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Erector spinae group

Patients in this group will receive bilateral erector spinae block at T10 level using 30ml of 0.25% Bupivacaine before surgical incision.

Group Type ACTIVE_COMPARATOR

Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Intervention Type DRUG

Bilateral Erector Spinae Block at T10 level using 30ml of 0.25% Bupivacaine will be administered under Ultrasound guidance before surgical incision.

Placebo

Patient in this group will receive Norma saline in Erector spinae block at T10 level bilaterally before surgical incision.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Bilateral Erector Spinae Block at T10 level using 30ml of Normal saline will be administered under Ultrasound guidance before surgical incision.

Interventions

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Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Bilateral Erector Spinae Block at T10 level using 30ml of 0.25% Bupivacaine will be administered under Ultrasound guidance before surgical incision.

Intervention Type DRUG

Placebo

Bilateral Erector Spinae Block at T10 level using 30ml of Normal saline will be administered under Ultrasound guidance before surgical incision.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) class: I, II and III .
* Elective Hysterectomy under General Anesthesia.

Exclusion Criteria

* Lack of consent
* Body mass index \>35 kg/m2
* Allergic to study medicine
* Opioid abuse or misuse disorder
* Chronic pain
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kulsoom International Hospital

OTHER

Sponsor Role lead

Responsible Party

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Waqas Anjum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kulsoom Internation Hospital

Islamabad, Federal, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Waqas Anjum, Principal Investigator, MBBS, FCPS

Role: CONTACT

+92-310-3308158

Abdul Rehman, MBBS,FCPS

Role: CONTACT

+92-333-5227329

Facility Contacts

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Nimra Member Ethics Review Committee, MBBS,FCPS

Role: primary

+92-334-5120067

References

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Hamed MA, Boules ML, Mahmoud MAEM, Abdelghaffar RA. The effect of erector spinae plane block on fentanyl consumption during open abdominal hysterectomy: a randomised controlled study. BMC Anesthesiol. 2023 Jun 5;23(1):194. doi: 10.1186/s12871-023-02156-3.

Reference Type BACKGROUND
PMID: 37277703 (View on PubMed)

Other Identifiers

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ERC-030

Identifier Type: -

Identifier Source: org_study_id

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