Post Operative PainNCT05717530
The Effect of Local Anesthetic Infiltration or Erector Spina Plan Block on Stress Hormone Response
A study testing wound site local anesthesic infiltration and Erector spina plane block in people with Post Operative Pain and Erector Spinae Plane Block, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery. Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Erector Spinae Plane Block, Inguinal Hernia
- What is being tested?
- wound site local anesthesic infiltration and Erector spina plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 7 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- who will undergo laparoscopic cholecystectomy
- ASA (American Society of Anesthesiology) I-II
- 18-65 age group
- operated between 08:00-12:00 in the morning
Who cannot join
- Pregnant,
- Diabetes Mellitus
- Emergency surgery
- ASA (American Society of Anesthesiology)III-IV
- Patients who did not consent to the study,
- History of local anesthetic allergy,
Show all 13Show fewer
- Coagulation disorder,
- Morbid obesity (body mass index >40 kg/m²),
- Severe organ failure,
- Previous neurological deficit,
- Psychiatric disease,
- Patients with a history of chronic pain
- Who were switched to the open procedure due to surgical complications during the operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Şişli, Istanbul, 34376
About this study
Official title: The Effect of Local Anesthetic Infiltration Into Wound Site or Erector Spina Plan Block on Stress Hormone Response and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy Surgery
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery.
Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response
Read the detailed description
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery. Abdominal and shoulder pain are frequently seen in patients in the postoperative period.
Laparoscopic surgery is considered the gold standard in abdominal surgery because of its low cost, less postoperative pain, early mobilization, and short hospital stay. Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. In laparoscopic cholecystectomy operations, the results of pain reduction and analgesic consumption in incisional local anesthetics are variable.
Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response .
In various surgeries, regional anesthesia for post-operative purposes, plan blocks, infiltration or insufflation methods were found to suppress the stress response.
In this study, the investigator aimed to compare the effects of local anesthetic infiltration at the wound site and erector spine plane block on stress hormone response and postoperative analgesia in patients who will undergo laparoscopic cholecystectomy surgery.
- Being tested
- wound site local anesthesic infiltration, Erector spina plane block
- Keywords
- Cholecystectomy, Laparoscopic, Erector spinae plane block, analgesia, cortisol, prolactin
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound site local anesthesic infiltrationProcedure or surgery
: at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site.
Erector spina plane blockProcedure or surgery
Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction.
| Study group | Role | What they receive |
|---|---|---|
| wound site local anesthesic infiltration | Active comparator | at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site Receives: Procedure: wound site local anesthesic infiltration |
| Erector spinae plane block | Active comparator | : Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction Receives: Procedure: Erector spina plane block |
| Control | No intervention | There was no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress hormone response
Blood was taken and recorded in a yellow capped gel biochemistry tube (SSTTM II Advance Tubes) for the measurement of stress hormone glucose(70-100 mg/dl), prolactin(4.79-23.3µg/dL), and cortisol(60.2-184 µg/dL) 1 hour before and 1 hour after the operation.
Measured: 5 hour
Secondary outcomes (2)
Visual Analog Pain Scale
visual analog for pain consist of a horizontal line, usually 100 mm in length. the left end of the line signifies no pain which is depicted by a smiling face while the right end signifies the worst possible pain with a frowning face. this visual depiction of pain levels helps the patient to communicate about the intensity of their pain.
Measured: 24 hour
Analgesia period
The time from the end of the operation to the first analgesic requirement was determined as the "analgesia period" and this time was recorded.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Feb 2023
- Primary completion1 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, murat sahin, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- murat sahin, Principal investigator, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717530
- Sponsor's protocol ID
- 5234
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anesthetic Infiltration Into Wound Site or Erector Spina Plan Block on Stress Hormone Response and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT05717530
- Acronym / sponsor ID
- 5234
- Keywords
- Cholecystectomy, Laparoscopic, Erector spinae plane block, analgesia, cortisol, prolactin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 8 Feb 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.
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery.
Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response
Detailed description
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery. Abdominal and shoulder pain are frequently seen in patients in the postoperative period.
Laparoscopic surgery is considered the gold standard in abdominal surgery because of its low cost, less postoperative pain, early mobilization, and short hospital stay. Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. In laparoscopic cholecystectomy operations, the results of pain reduction and analgesic consumption in incisional local anesthetics are variable.
Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response .
In various surgeries, regional anesthesia for post-operative purposes, plan blocks, infiltration or insufflation methods were found to suppress the stress response.
In this study, the investigator aimed to compare the effects of local anesthetic infiltration at the wound site and erector spine plane block on stress hormone response and postoperative analgesia in patients who will undergo laparoscopic cholecystectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| wound site local anesthesic infiltration | Active comparator | Procedure: wound site local anesthesic infiltrationat the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site |
| Erector spinae plane block | Active comparator | Procedure: Erector spina plane block: Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction |
| Control | No intervention | –There was no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- who will undergo laparoscopic cholecystectomy
- ASA (American Society of Anesthesiology) I-II
- 18-65 age group
- operated between 08:00-12:00 in the morning
Key exclusion criteria (13 listed)
- Pregnant,
- Diabetes Mellitus
- Emergency surgery
- ASA (American Society of Anesthesiology)III-IV
- Patients who did not consent to the study,
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 |
|---|---|---|
| wound site local anesthesic infiltration: at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site. | Procedure or surgery | wound site local anesthesic infiltration |
| Erector spina plane blockErector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction. | Procedure or surgery | Erector spinae plane block |
Primary outcome
Stress hormone response
Time frame: 5 hour
Blood was taken and recorded in a yellow capped gel biochemistry tube (SSTTM II Advance Tubes) for the measurement of stress hormone glucose(70-100 mg/dl), prolactin(4.79-23.3µg/dL), and cortisol(60.2-184 µg/dL) 1 hour before and 1 hour after the operation.
2 secondary outcomes
Visual Analog Pain Scale
Time frame: 24 hour
Analgesia period
Time frame: 24 hour
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 29 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
murat sahin principal investigator
şişli etfal eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound site local anesthesic infiltration and Erector spina plane block in people with Post Operative Pain and Erector Spinae Plane Block, run by Sisli Hamidiye Etfal Training and Research 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 4 inclusion and 13 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 29 Jan 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 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?
Stress hormone response (time frame: 5 hour). 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 29 Jan 2025.