Erector Spinae BlockPhase 4NCT07178262
Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy
A Phase 4 study testing Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) in people with Erector Spinae Block and Enhanced Recovery After Surgery (ERAS) Protocol, run by Kulsoom International Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erector Spinae Block, Enhanced Recovery After Surgery (ERAS) Protocol, Opioid
- What is being tested?
- Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class: I, II and III .
- Elective Hysterectomy under General Anesthesia.
Who cannot join
- Lack of consent
- Body mass index >35 kg/m2
- Allergic to study medicine
- Opioid abuse or misuse disorder
- Chronic pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Kulsoom Internation Hospital
Islamabad, Federal, 44000
Nimra Member Ethics Review Committee, MBBS,FCPS, +92-334-5120067
About this study
Official title: Opioid Sparing Effect of Erector Spinae Block in Patients Undergoing Total Abdominal Hysterectomy; A Randomized Control Trial
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.
Read the detailed description
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.
- Being tested
- Erector Spinae (ESP) Block with Bupivacaine (Marcaine®), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Bilateral Erector Spinae Block at T10 level using 30ml of Normal saline will be administered under Ultrasound guidance before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Intra-operative Fentanyl consumption
Measured: From surgical incision till end of surgery
Secondary outcomes (2)
Total amount of IV Tramadol consumed in post operative period
Measured: First 24 hours after surgery
Post operative pain score
This will be assessed Visual Analog Scale
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Aug 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kulsoom International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqas Anjum, Kulsoom International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178262
- Sponsor's protocol ID
- ERC-030
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37277703
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Sparing Effect of Erector Spinae Block in Patients Undergoing Total Abdominal Hysterectomy; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07178262
- Acronym / sponsor ID
- ERC-030
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kulsoom International HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae group | Active comparator | Drug: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Patients in this group will receive bilateral erector spinae block at T10 level using 30ml of 0.25% Bupivacaine before surgical incision. |
| Placebo | Placebo comparator | Drug: PlaceboPatient in this group will receive Norma saline in Erector spinae block at T10 level bilaterally before surgical incision. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class: I, II and III .
- Elective Hysterectomy under General Anesthesia.
Key exclusion criteria (5 listed)
- Lack of consent
- Body mass index >35 kg/m2
- Allergic to study medicine
- Opioid abuse or misuse disorder
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Erector spinae group |
| PlaceboBilateral Erector Spinae Block at T10 level using 30ml of Normal saline will be administered under Ultrasound guidance before surgical incision. | Drug | Placebo |
Primary outcome
Total Intra-operative Fentanyl consumption
Time frame: From surgical incision till end of surgery
2 secondary outcomes
Total amount of IV Tramadol consumed in post operative period
Time frame: First 24 hours after surgery
Post operative pain score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 37277703Hamed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) in people with Erector Spinae Block and Enhanced Recovery After Surgery (ERAS) Protocol, run by Kulsoom International Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waqas Anjum, Principal Investigator, MBBS, FCPS (+92-310-3308158, waqasanjum435@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intra-operative Fentanyl consumption (time frame: From surgical incision till end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.