Postoperative PainNCT05765318
Quadratus Lumborum Block for Total Abdominal Hysterectomy
A study testing QLB in people with Postoperative Pain, run by Clinical Center Niš at 1 site in Serbia.
Trial summary
Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- QLB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 27 Feb 2023to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endometrial carcinoma or uterine fibroids
- American society of anesthesiologists (ASA) physical status 1-3,
- Participant's body weight > 50 kg,
- Written informed consent signed.
Who cannot join
- Patient's refusal
- Allergies to any study medication
- Local skin infection on the site of QLB injection
- 3. Body mass index > 40 kg/m2 4. Inability to comprehend or participate in scoring scales 4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane 5. Quadratus lumborum muscle plane not seen in ultrasound examination 6. Patients on regular use of opioids 7. Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block for Total Abdominal Hysterectomy: a Double-blind, Randomized, Controlled Trial
Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Multimodal postoperative pain management plane includes cyclooxygenase-2 (COX-2) selective inhibitors, and/or conventional non-steroidal antiinflammatory drugs (NSAID) in combination with strong opioids for high-intensity pain or with weak opioids for moderate- or low-intensity pain. Paracetamol also was recommended in combination with COX-2 inhibitors or conventional NSAIDs. Epidural analgesia was recommended for high-risk patients. PROSPECT guidelines updated in 2018 discuss only perioperative approach for laparoscopic hysterectomy. However, hysterectomy technique has been switched from total abdominal to laparoscopic approach. In low resources settings, laparoscopic technique is nor well developed neither available to many patients. Furthermore, the majority of patients undergo total abdominal hysterectomy (TAH), that is very painful procedure. Quadratus lumborum block (QLB) is a regional analgesic technique described by Blanco in 2007. Society for Obstetric Anesthesiology and Perinatology (SOAP) and European Society for Regional Anaesthesia and Pain Therapy (ESRA) recommended QLB for post-Cesarean pain management in cases where intrathecal morphine could not be used or for breakthrough pain. Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. The effects of QLB for laparoscopic hysterectomy is controversial. We would like to see if QLB can provide analgesic benefits in multimodal pain management after TAH in our clinical settings.
Read the detailed description
Participants will be randomly allocated into two groups. Experimental group will have QLB type 2 at the end of surgery, before emergence from general anesthesia. Control group will not have QLB.
All cases will be done under general anesthesia. During the surgery, the patients will be monitored with 5-lead electrocardiography, pulse oximetry, non-invasive blood pressure and end-expiratory CO2.
Standardized general anesthesia include induction with a propofol bolus of 1.5-2.5mg/kg and rocuronium 0.6mg/kg. Fentanyl 2 mcg/kg will be given at induction, and repeated to keep the blood pressure and heart rate changes up to 20% of baseline. Sevoflurane in a 50% air/50% oxygen mixture with an end-tidal of 1.5 vol% will be used as the maintenance agent. Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Incremental dose of rocuronium (0.15 mg/kg) will be given every 30 min or when needed. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation. Participants will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery.
Postoperative pain management will include ketoprofen and morphine.
- Conditions
- Postoperative Pain
- Being tested
- QLB
- Keywords
- Quadratus lumborum block, Postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLBProcedure or surgery
QLB is ultrasound-guided injection of 30 ml bupivacaine 0.25% into quadratus lumborum plane posterior to the end of internal oblique muscle.
| Study group | Role | What they receive |
|---|---|---|
| QLB group | Experimental | At the end of surgery, before emergence of anesthesia, participants will receive bilateral QLB and intravenous (IV) ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours.
For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. Receives: Procedure: QLB |
| Control group | No intervention | At the end of surgery, before emergence of anesthesia, participants will receive IV ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption (mg) during the first 12 postoperative hours
Total dose of IV morphine that participants received during the first 12 hours after surgery
Measured: 12 hours after the end of surgery
Secondary outcomes (4)
Pain at rest
Pain at rest at NRS (Numeric rating scale score 0-10)
Measured: 2, 6, 12, and 24 hours after surgery
Pain at mobilization
Pain at mobilization at NRS (Numeric rating scale score 0-10)
Measured: 2, 6, 12, and 24 hours after surgery
Cumulated morphine consumption (mg) at 24 hours postoperatively
Total dose of IV morphine that participants received during the first 24 hours after surgery
Measured: 24 hours after the end of surgery
Time to first morphine demand
Time to first request for rescue analgesia (morphine) after the end of surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start27 Feb 2023
- Primary completion8 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Center Niš
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija Kutlesic, Clinical Center Niš
- Investigators
- Nada Pejcic, M.D., Principal investigator, Leskovac General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765318
- Sponsor's protocol ID
- 150880200222
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers engaging in independent scientific research could request data via email address: nada.pejcic@gmail.com
Publications
Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.
PubMed 30914471Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.
PubMed 33370462Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
PubMed 33177330Akerman M, Pejcic N, Velickovic I. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne). 2018 Feb 26;5:44. doi: 10.3389/fmed.2018.00044. eCollection 2018.
PubMed 29536008Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
PubMed 33082286Pejcic N, Kutlesic M, Velickovic I, Milic V, Kovacevic S, Jankovic RJ, Mitic D, Mitic R, Zornic N. Quadratus lumborum block for total abdominal hysterectomy: a double-blind, randomized, controlled trial. Turk J Med Sci. 2025 Feb 7;55(2):349-359. doi: 10.55730/1300-0144.5978. eCollection 2025.
PubMed 40342315
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block for Total Abdominal Hysterectomy: a Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05765318
- Acronym / sponsor ID
- 150880200222
- Conditions
- Postoperative Pain
- Keywords
- Quadratus lumborum block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinical Center NišUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 13 Mar 2023 (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.
Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Multimodal postoperative pain management plane includes cyclooxygenase-2 (COX-2) selective inhibitors, and/or conventional non-steroidal antiinflammatory drugs (NSAID) in combination with strong opioids for high-intensity pain or with weak opioids for moderate- or low-intensity pain. Paracetamol also was recommended in combination with COX-2 inhibitors or conventional NSAIDs. Epidural analgesia was recommended for high-risk patients. PROSPECT guidelines updated in 2018 discuss only perioperative approach for laparoscopic hysterectomy. However, hysterectomy technique has been switched from total abdominal to laparoscopic approach. In low resources settings, laparoscopic technique is nor well developed neither available to many patients. Furthermore, the majority of patients undergo total abdominal hysterectomy (TAH), that is very painful procedure. Quadratus lumborum block (QLB) is a regional analgesic technique described by Blanco in 2007. Society for Obstetric Anesthesiology and Perinatology (SOAP) and European Society for Regional Anaesthesia and Pain Therapy (ESRA) recommended QLB for post-Cesarean pain management in cases where intrathecal morphine could not be used or for breakthrough pain. Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. The effects of QLB for laparoscopic hysterectomy is controversial. We would like to see if QLB can provide analgesic benefits in multimodal pain management after TAH in our clinical settings.
Detailed description
Participants will be randomly allocated into two groups. Experimental group will have QLB type 2 at the end of surgery, before emergence from general anesthesia. Control group will not have QLB.
All cases will be done under general anesthesia. During the surgery, the patients will be monitored with 5-lead electrocardiography, pulse oximetry, non-invasive blood pressure and end-expiratory CO2.
Standardized general anesthesia include induction with a propofol bolus of 1.5-2.5mg/kg and rocuronium 0.6mg/kg. Fentanyl 2 mcg/kg will be given at induction, and repeated to keep the blood pressure and heart rate changes up to 20% of baseline. Sevoflurane in a 50% air/50% oxygen mixture with an end-tidal of 1.5 vol% will be used as the maintenance agent. Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Incremental dose of rocuronium (0.15 mg/kg) will be given every 30 min or when needed. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation. Participants will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery.
Postoperative pain management will include ketoprofen and morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB group | Experimental | Procedure: QLBAt the end of surgery, before emergence of anesthesia, participants will receive bilateral QLB and intravenous (IV) ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. |
| Control group | No intervention | –At the end of surgery, before emergence of anesthesia, participants will receive IV ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- endometrial carcinoma or uterine fibroids
- American society of anesthesiologists (ASA) physical status 1-3,
- Participant's body weight > 50 kg,
- Written informed consent signed.
Key exclusion criteria (4 listed)
- Patient's refusal
- Allergies to any study medication
- Local skin infection on the site of QLB injection
- 3. Body mass index > 40 kg/m2 4. Inability to comprehend or participate in scoring scales 4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane 5. Quadratus lumborum muscle plane not seen in ultrasound examination 6. Patients on regular use of opioids 7. Psychiatric disorders
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 |
|---|---|---|
| QLBQLB is ultrasound-guided injection of 30 ml bupivacaine 0.25% into quadratus lumborum plane posterior to the end of internal oblique muscle. | Procedure or surgery | QLB group |
Primary outcome
Morphine consumption (mg) during the first 12 postoperative hours
Time frame: 12 hours after the end of surgery
Total dose of IV morphine that participants received during the first 12 hours after surgery
4 secondary outcomes
Pain at rest
Time frame: 2, 6, 12, and 24 hours after surgery
Pain at mobilization
Time frame: 2, 6, 12, and 24 hours after surgery
Cumulated morphine consumption (mg) at 24 hours postoperatively
Time frame: 24 hours after the end of surgery
Time to first morphine demand
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 30914471Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.
- Background: PubMed 33370462Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.
- Background: PubMed 33177330Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
- Background: PubMed 29536008Akerman M, Pejcic N, Velickovic I. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne). 2018 Feb 26;5:44. doi: 10.3389/fmed.2018.00044. eCollection 2018.
- Results publication: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Results publication: PubMed 33082286Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
- Derived from this study: PubMed 40342315Pejcic N, Kutlesic M, Velickovic I, Milic V, Kovacevic S, Jankovic RJ, Mitic D, Mitic R, Zornic N. Quadratus lumborum block for total abdominal hysterectomy: a double-blind, randomized, controlled trial. Turk J Med Sci. 2025 Feb 7;55(2):349-359. doi: 10.55730/1300-0144.5978. eCollection 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers engaging in independent scientific research could request data via email address: nada.pejcic@gmail.com
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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. This study is not recruiting at the moment.
Nada Pejcic, M.D. principal investigator
Leskovac General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLB in people with Postoperative Pain, run by Clinical Center Niš at 1 site in Serbia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Serbia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (mg) during the first 12 postoperative hours (time frame: 12 hours after the 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 NCT05765318, which also lists 7 linked publications.
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 13 Feb 2024.