Postoperative PainNCT05965674
Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain
A study testing Sacral Erector Spinae Plane Block in people with Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sacral Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 7 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being between the ages of 18 and 65,
- having an ASA status of 1-2.
Who cannot join
- under the age of 18, pregnant individuals,
- significant hematopoietic, cardiovascular, liver, or kidney disorders,
- patients unable to comply with medical instructions, individuals on anticoagulant therapy, and those with contraindications to regional anesthetic agents or a history of previous hemorrhoidectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Postoperative pain is a significant concern, with over 80% of patients encountering moderate to severe pain.
The main aim is to evaluate ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also aimed if sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, our main objective was to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
Read the detailed description
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Postoperative pain is a significant concern, with over 80% of patients encountering moderate to severe pain. This heightened pain level contributes to an elevated risk of complications including atelectasis, thromboembolism, myocardial ischemia, cardiac arrhythmia, electrolyte imbalance, urinary retention, and ileus. The two main unresolved issues following surgery are postoperative pain and urinary retention. In addition to improving patient satisfaction, pain management will decrease urinary retention and constipation, especially in the first 24 hours following surgery. According to earlier research, even with analgesic therapy, 20% to 40% of patients who underwent hemorrhoidectomy would experience severe postoperative pain. Commonly used pain relievers like nonsteroidal anti-inflammatory drugs, paracetamol, and opioids often come with adverse effects such as dizziness, nausea, vomiting, and constipation and can even lead to tolerance. These side effects could prevent a full recovery and result in a poor prognosis. Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain, but they are technically difficult and require specific positioning. Furthermore, the administration of pudendal nerve block carries the risk of potential complications, including hematoma formation, sciatic nerve injury, and accidental rectal puncture. Therefore, an alternative analgesic method with minimal adverse effects would be beneficial.
The erector spinae plane block (ESPB) was initially introduced as an interfascial plane block performed at the upper thoracic levels with the purpose of alleviating neuropathic pain. Subsequently, its application expanded to encompass a range of thoracic interventions, including mastectomy, video-assisted thoracoscopy (VATS), and cardiac surgery, while also being utilized at lumbar levels for procedures such as abdominal surgery, prostatectomy, lumbar spine surgery, total hip arthroplasty, and proximal femur surgery. A newly introduced method called the sacral Erector Spinae Plane Block (ESPB) has been recently documented in scientific literature. Case studies have demonstrated its effectiveness in various surgical procedures. Specifically, it has shown promise in managing radicular pain at the L5-S1 level after sex reassignment surgery and hypospadias surgery, as well as providing analgesia for the posterior branches of the sacral nerves during pilonidal sinus surgery.
The main hypothesis is that performing ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also hypothesized that sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, the main objective is to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
- Conditions
- Postoperative Pain
- Being tested
- Sacral Erector Spinae Plane Block
- Keywords
- Sacral Erector Spinae Plane Block, Post-Hemorrhoidectomy Pain, Analgesic consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral Erector Spinae Plane BlockProcedure or surgery
The transducer will be placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) will be injected between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| The sacral ESPB group (Group S) | Active comparator | Patients in Group S underwent a procedure where a high-frequency linear ultrasound probe (Clarius, 205-2980 Virtual Way, Vancouver, BC, Canada V5M 4X3 MyLabFive; Esaote Europe BV Philipsweg 1 6227 AJ, Maastricht, the Netherlands) was positioned on the transverse plane, specifically on the fifth spinous process. The probe was then moved downwards to visualize the first and second median sacral crest. Next, the transducer was placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) was injected between the erector spinae muscles and the intermediate sacral crest. The same procedure was performed on the contralateral side. Receives: Procedure: Sacral Erector Spinae Plane Block |
| The control group (Group N) | No intervention | It will not be performed any extra intervention, just rutin clinic protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
The primary outcome is pain score at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
Measured: Perioperative period
Secondary outcomes (1)
The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
The secondary outcome measures are the cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydın Mermer, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965674
- Sponsor's protocol ID
- KonyaCityH Study Hemo
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain
- ClinicalTrials.gov ID
- NCT05965674
- Acronym / sponsor ID
- KonyaCityH Study Hemo
- Conditions
- Postoperative Pain
- Keywords
- Sacral Erector Spinae Plane Block, Post-Hemorrhoidectomy Pain, Analgesic consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 28 Jul 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.
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Postoperative pain is a significant concern, with over 80% of patients encountering moderate to severe pain.
The main aim is to evaluate ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also aimed if sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, our main objective was to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
Detailed description
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Postoperative pain is a significant concern, with over 80% of patients encountering moderate to severe pain. This heightened pain level contributes to an elevated risk of complications including atelectasis, thromboembolism, myocardial ischemia, cardiac arrhythmia, electrolyte imbalance, urinary retention, and ileus. The two main unresolved issues following surgery are postoperative pain and urinary retention. In addition to improving patient satisfaction, pain management will decrease urinary retention and constipation, especially in the first 24 hours following surgery. According to earlier research, even with analgesic therapy, 20% to 40% of patients who underwent hemorrhoidectomy would experience severe postoperative pain. Commonly used pain relievers like nonsteroidal anti-inflammatory drugs, paracetamol, and opioids often come with adverse effects such as dizziness, nausea, vomiting, and constipation and can even lead to tolerance. These side effects could prevent a full recovery and result in a poor prognosis. Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain, but they are technically difficult and require specific positioning. Furthermore, the administration of pudendal nerve block carries the risk of potential complications, including hematoma formation, sciatic nerve injury, and accidental rectal puncture. Therefore, an alternative analgesic method with minimal adverse effects would be beneficial.
The erector spinae plane block (ESPB) was initially introduced as an interfascial plane block performed at the upper thoracic levels with the purpose of alleviating neuropathic pain. Subsequently, its application expanded to encompass a range of thoracic interventions, including mastectomy, video-assisted thoracoscopy (VATS), and cardiac surgery, while also being utilized at lumbar levels for procedures such as abdominal surgery, prostatectomy, lumbar spine surgery, total hip arthroplasty, and proximal femur surgery. A newly introduced method called the sacral Erector Spinae Plane Block (ESPB) has been recently documented in scientific literature. Case studies have demonstrated its effectiveness in various surgical procedures. Specifically, it has shown promise in managing radicular pain at the L5-S1 level after sex reassignment surgery and hypospadias surgery, as well as providing analgesia for the posterior branches of the sacral nerves during pilonidal sinus surgery.
The main hypothesis is that performing ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also hypothesized that sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, the main objective is to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The sacral ESPB group (Group S) | Active comparator | Procedure: Sacral Erector Spinae Plane BlockPatients in Group S underwent a procedure where a high-frequency linear ultrasound probe (Clarius, 205-2980 Virtual Way, Vancouver, BC, Canada V5M 4X3 MyLabFive; Esaote Europe BV Philipsweg 1 6227 AJ, Maastricht, the Netherlands) was positioned on the transverse plane, specifically on the fifth spinous process. The probe was then moved downwards to visualize the first and second median sacral crest. Next, the transducer was placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) was injected between the erector spinae muscles and the intermediate sacral crest. The same procedure was performed on the contralateral side. |
| The control group (Group N) | No intervention | –It will not be performed any extra intervention, just rutin clinic protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being between the ages of 18 and 65,
- having an ASA status of 1-2.
Key exclusion criteria (3 listed)
- under the age of 18, pregnant individuals,
- significant hematopoietic, cardiovascular, liver, or kidney disorders,
- patients unable to comply with medical instructions, individuals on anticoagulant therapy, and those with contraindications to regional anesthetic agents or a history of previous hemorrhoidectomy.
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 |
|---|---|---|
| Sacral Erector Spinae Plane BlockThe transducer will be placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) will be injected between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side. | Procedure or surgery | The sacral ESPB group (Group S) |
Primary outcome
pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
Time frame: Perioperative period
The primary outcome is pain score at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
1 secondary outcome
The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
Time frame: Perioperative period
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 28 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Erector Spinae Plane Block in people with Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 3 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 28 Jul 2023. 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 Turkey (Türkiye). 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?
pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h. (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.