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

NCT07178262 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: ERC-030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Total Intra-operative Fentanyl consumption

  From surgical incision till end of surgery

Secondary Outcomes (2)

• Total amount of IV Tramadol consumed in post operative period

  First 24 hours after surgery

• Post operative pain score

  Baseline that is pain score upon arrival in post anesthesia care unit in the post operative period and then at 1hours ,2 hours ,4 hours,6 hours,12 hours and 24 hours in the post operative period

Study Arms (2)

Erector spinae group

ACTIVE COMPARATOR

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

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

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

Erector spinae group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kulsoom International Hospital: lead

Study Sites (1)

Kulsoom Internation Hospital

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37277703 BACKGROUND

MeSH Terms

Interventions

Parapsychology; Dental Occlusion; Bupivacaine

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Waqas Anjum, Principal Investigator, MBBS, FCPS

CONTACT

+92-310-3308158; waqasanjum435@gmail.com

Abdul Rehman, MBBS,FCPS

CONTACT

+92-333-5227329; rehman222@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 17, 2025
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)