Postoperative Quality of RecoveryNCT06684262
Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy
An observational study of Postoperative Quality of Recovery and Postoperative Analgesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Quality of Recovery, Postoperative Analgesia
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2024to 15 Oct 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Will undergo laparoscopic cholecystectomy operation, * Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.
Who may be able to join
- Will undergo laparoscopic cholecystectomy operation,
- Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.
Who cannot join
- Patients who do not give consent
- Those who are allergic to the drugs used in the research
- Those with coagulation disorders
- Having a history of alcohol and substance use
- Having a history of serious psychiatric and neurological diseases
- Having chronic pain syndrome
- Those with local infection in the area to be blocked
- Patients with sepsis and undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Erector Spina Plane Block and Intraperitoneal Local Anesthetic Infiltration on the Quality of Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy.
Laparoscopic cholecystectomy is a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Both Erector Spinae Plane Block and Intraperitoneal Local Anesthetic Infiltration method are methods used to reduce postoperative pain. However, there is no study in the literature comparing these 2 methods in terms of postoperative recovery quality. In this study, patients will receive Erector Spinae Plane Block or Intraperitoneal Local Anesthetic Infiltration at the end of surgery, and both techniques will be compared using the preoperative and postoperative quality of recovery 40 survey.
Read the detailed description
The Preoperative Quality of Recovery 40 questionnaire will be administered to patients scheduled for laparoscopic cholecystectomy who consent to participate in the study. Following the surgical procedure, patients will receive either intraperitoneal local anesthetic infiltration or bilateral erector spinae plane block for postoperative analgesia. These interventions will be examined in an observational study comprising two distinct groups. At the 24-hour mark postoperatively, the Quality of Recovery 40 (QoR 40) survey will be readministered to the patients, and the outcomes will be subjected to comparative analysis. Throughout the postoperative period, patients in both cohorts will be closely monitored. Pain scores and opioid-associated adverse effects (such as nausea, vomiting, and pruritus) will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th hours. Subsequent to the surgical procedure, patients in both groups will be provided with morphine via patient-controlled analgesia, and the extent of opioid consumption within the first 24 hours postoperatively will be compared.
Primary purpose: To compare the effects of Erector Spina Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy.
Secondary objectives: To compare the effects of ESP block and intraperitoneal local anesthetic infiltration on postoperative pain scores at rest and with movement, total opioid consumption, and incidence of opioid-related side effects in patients undergoing laparoscopic cholecystectomy.
- Keywords
- Erector Spina Plane Block, intraperitoneal instillation of local anesthetics, Postoperative quality of recovery, Postoperative analgesia, laparoscopic cholecystectomy, intraperitoneal infiltration of local anaesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group IPLA | Following the extraction of the gallbladder, the surgical team promptly administers a 45 mL local anesthetic solution blend consisting of 20 mL of bupivacaine at a concentration of 0.5%, 10 mL of lidocaine at a concentration of 2%, and 15 mL of 0.9% saline solution to the gallbladder bed and subdiaphragmatic region. This administration is performed via an aspiration catheter under direct visualization provided by the laparoscopic camera | |
| Group ESP | At the end of the operation and before tracheal extubation, patients will be turned into the lateral decubitus position. Bilateral erector spinae plane block will be applied at the T8 spinous process level. Under asepsis-antisepsis standards, a 12 mHz linear ultrasound probe will be placed approximately 3 cm lateral to the spinous process of the T8 vertebra in a longitudinal parasagittal orientation. After identification of the trapezius, rhomboid major, erector spinae muscles and transverse process, an aspiration test using an 80 mm peripheral nerve block needle, 22.5 ml of local anesthetic mixture (10 mL bupivacaine at 0.5% concentration, 5 mL lidocaine at 2% concentration, 7.5 mL 0.9% NaCl) will be applied bilaterally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of postoperative recovery
The aim of this study was to use the Quality of Recovery 40 questionnaire as a method to evaluate and compare the effects of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy. The QoR-40 questionnaire is a self-assessment questionnaire used to evaluate the quality of postoperative recovery. It is a questionnaire that evaluates the level of pain, physical and emotional status of patients and consists of 40 questions and five domains: emotional status (n=9), comfort (n=12), psychological support (n=7), physical independence (n=5) and pain (n=7). Each question is scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst quality of recovery) to 200 (best quality of recovery). A low total score indicates poor quality of recovery; a high total score indicates good quality of recovery.
Measured: postoperative 24th hour
Secondary outcomes (2)
Postoperative pain
To evaluate and contrast the impact of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on postoperative pain levels during rest and movement, as measured by the numerical pain rating scale (ranging from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain), among patients undergoing laparoscopic cholecystectomy.Higher numerical pain scale scores indicate higher pain levels, and lower scores indicate lower pain levels.
Measured: Postoperative 1st-2nd-4th-8th-12th-24th hours
Postoperative opioid consumption
To compare the 24-hour postoperative morphine consumption in milligrams after Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration.
Measured: for 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start16 Feb 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Duzla MD, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684262
- Sponsor's protocol ID
- 2024000006-4
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Erector Spina Plane Block and Intraperitoneal Local Anesthetic Infiltration on the Quality of Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT06684262
- Acronym / sponsor ID
- 2024000006-4
- Keywords
- Erector Spina Plane Block, intraperitoneal instillation of local anesthetics, Postoperative quality of recovery, Postoperative analgesia, laparoscopic cholecystectomy, intraperitoneal infiltration of local anaesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 12 Nov 2024 (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 a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Both Erector Spinae Plane Block and Intraperitoneal Local Anesthetic Infiltration method are methods used to reduce postoperative pain. However, there is no study in the literature comparing these 2 methods in terms of postoperative recovery quality. In this study, patients will receive Erector Spinae Plane Block or Intraperitoneal Local Anesthetic Infiltration at the end of surgery, and both techniques will be compared using the preoperative and postoperative quality of recovery 40 survey.
Detailed description
The Preoperative Quality of Recovery 40 questionnaire will be administered to patients scheduled for laparoscopic cholecystectomy who consent to participate in the study. Following the surgical procedure, patients will receive either intraperitoneal local anesthetic infiltration or bilateral erector spinae plane block for postoperative analgesia. These interventions will be examined in an observational study comprising two distinct groups. At the 24-hour mark postoperatively, the Quality of Recovery 40 (QoR 40) survey will be readministered to the patients, and the outcomes will be subjected to comparative analysis. Throughout the postoperative period, patients in both cohorts will be closely monitored. Pain scores and opioid-associated adverse effects (such as nausea, vomiting, and pruritus) will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th hours. Subsequent to the surgical procedure, patients in both groups will be provided with morphine via patient-controlled analgesia, and the extent of opioid consumption within the first 24 hours postoperatively will be compared.
Primary purpose: To compare the effects of Erector Spina Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy.
Secondary objectives: To compare the effects of ESP block and intraperitoneal local anesthetic infiltration on postoperative pain scores at rest and with movement, total opioid consumption, and incidence of opioid-related side effects in patients undergoing laparoscopic cholecystectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group IPLA | – | –Following the extraction of the gallbladder, the surgical team promptly administers a 45 mL local anesthetic solution blend consisting of 20 mL of bupivacaine at a concentration of 0.5%, 10 mL of lidocaine at a concentration of 2%, and 15 mL of 0.9% saline solution to the gallbladder bed and subdiaphragmatic region. This administration is performed via an aspiration catheter under direct visualization provided by the laparoscopic camera |
| Group ESP | – | –At the end of the operation and before tracheal extubation, patients will be turned into the lateral decubitus position. Bilateral erector spinae plane block will be applied at the T8 spinous process level. Under asepsis-antisepsis standards, a 12 mHz linear ultrasound probe will be placed approximately 3 cm lateral to the spinous process of the T8 vertebra in a longitudinal parasagittal orientation. After identification of the trapezius, rhomboid major, erector spinae muscles and transverse process, an aspiration test using an 80 mm peripheral nerve block needle, 22.5 ml of local anesthetic mixture (10 mL bupivacaine at 0.5% concentration, 5 mL lidocaine at 2% concentration, 7.5 mL 0.9% NaCl) will be applied bilaterally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Will undergo laparoscopic cholecystectomy operation, * Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.
Key inclusion criteria (2 listed)
- Will undergo laparoscopic cholecystectomy operation,
- Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.
Key exclusion criteria (8 listed)
- Patients who do not give consent
- Those who are allergic to the drugs used in the research
- Those with coagulation disorders
- Having a history of alcohol and substance use
- Having a history of serious psychiatric and neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of postoperative recovery
Time frame: postoperative 24th hour
The aim of this study was to use the Quality of Recovery 40 questionnaire as a method to evaluate and compare the effects of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy. The QoR-40 questionnaire is a self-assessment questionnaire used to evaluate the quality of postoperative recovery. It is a questionnaire that evaluates the level of pain, physical and emotional status of patients and consists of 40 questions and five domains: emotional status (n=9), comfort (n=12), psychological support (n=7), physical independence (n=5) and pain (n=7). Each question is scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst quality of recovery) to 200 (best quality of recovery). A low total score indicates poor quality of recovery; a high total score indicates good quality of recovery.
2 secondary outcomes
Postoperative pain
Time frame: Postoperative 1st-2nd-4th-8th-12th-24th hours
Postoperative opioid consumption
Time frame: for 24 hours postoperatively
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 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Postoperative Quality of Recovery and Postoperative Analgesia, run by Ankara University 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 8 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 12 Nov 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 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?
Quality of postoperative recovery (time frame: postoperative 24th 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 12 Nov 2024.