Laparoscopic CholecystectomyNCT05755815
Retrolaminar Block Versus Intraperitoneal Block for Laparoscopic Cholecystectomy
A study testing retrolaminar block and Peritoneal block in people with Laparoscopic Cholecystectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
Although laparoscopic cholecystectomy is a minimally invasive surgery, it causes moderate-severe pain. The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- retrolaminar block and Peritoneal block
- 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 siteEgypt
- Study dates
- 21 May 2023to 15 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) 1 or 2 patients.
- Scheduled for laparoscopic cholecystectomy
Who cannot join
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
- Significant cardiac dysfunction, hepatic, or renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Retrolaminar Block Versus Intraperitoneal Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Cholecystectomy: Randomized, Controlled Trial
Although laparoscopic cholecystectomy is a minimally invasive surgery, it causes moderate-severe pain. The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating the differences between the two techniques. It is hypothesized that retrolaminar block will be comparable to peritoneal block as a promising effective alternative for analgesia for in laparoscopic cholecystectomy surgeries with fewer side effects.
Read the detailed description
Laparoscopic cholecystectomy (LC) provides many advantages as less pain, shorter hospital stay, and earlier recovery, and it is a cost-effective procedure. Although it is a minimally invasive surgery, it causes moderate-severe pain. Pain has several sources but mostly visceral pain caused by tissue trauma during gall bladder resection is the most predominant component. Acute pain after laparoscopic cholecystectomy does not match pain after other laparoscopic surgeries because of its complexity, so proper management of pain should be procedure-specific and multimodal. Many analgesic interventions with different mechanisms have been studied for their effects on pain relief after laparoscopic cholecystectomy. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. Ultrasound-guided retrolaminar block is a recent modified paravertebral technique for analgesia in thoracoabdominal procedures with a local anesthetic injected at the retrolaminar site. It has the advantage of being safe and easy compared with traditional thoracic epidural analgesia. It has a decreased incidence of complications such as hypotension, pleural disorder, and nerve injury.Intraperitoneal local anaesthetic administration has been used as a method for reducing postoperative pain. Intraperitoneal local anaesthetics acts on visceral nociceptors of peritoneum.Therefore, this study will be conducted to evaluate efficacy and safety of ultrasound guided retrolaminar block for postoperative analgesia in laparoscopic cholecystectomy surgery in comparison to intraperitoneal local anaesthetic administration.
Aim of the Study:
The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating the differences between the two techniques. It is hypothesized that retrolaminar block will be comparable to peritoneal block as a promising effective alternative for analgesia for in laparoscopic cholecystectomy surgeries with fewer side effects.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with time to first analgesic request as the primary outcome. Using the results published by ahmed et al 2021 with the mean time to first analgesic request in intraperitoneal instillation group was (2.88 ± 0.33 hours). Using a two-sided two-sample unequal-variance t-test., sample size of 54 patients is needed to achieve 90% power to detect 10 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. A 10% drop out is considered, so a total of 60 patients will be enrolled (30 in each group) in this study
Methods:
The study will be conducted in Mansoura university hospital on sixty patients Who is Scheduled for laparoscopic cholecystectomy.They will be randomly assigned to two equal groups (retrolaminar group and peritoneal group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent. Patient demographic data including age, sex and body weight will be recorded. A written informed consent will be obtained from all study subjects after ensuring confidentiality. The study protocol will be explained along with VAS to all patients after enrollment into the study. In both groups, the block will be under strict aseptic conditions after patient intubation and before skin incision.
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS(Statistical Package for the Social Sciences) program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± SD (Standard deviation)and compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range) and compared with the Mann-Whitney U test. Repeated measures ANOVA will be used for comparisons within the same group. Categorical data will be presented as number (percentage) and compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.Conditions
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- retrolaminar block, Peritoneal block
- Keywords
- retrolaminar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrolaminar blockProcedure or surgery
A high-frequency 12 MHz linear ultrasound probe will be used, patients will receive bilateral ultrasound-guided retrolaminar plane block with 20 mL of bupivacaine 0.25%. Their spines will be palpated from the vertebra prominens caudally to T7 and point will be marked to identify the spinous processes, which will be confirmed by ultrasound through counting from T12 with the characteristic last rib attached to its transverse process upward to the T7 lamina. The linear high frequency transducer (6-13 MHz) will be placed in the parasagittal plane one cm lateral to the midline. The needle will be inserted in the in-plane view of the ultrasound probe and will be advanced from downward to upward to target the T7 posterior lamina surface at an angle of 90˚ to the skin until the needle tip will be contacted the posterior surface of targeted lamina . After negative aspiration, 20 mL of bupivacaine 0.25% will be injected. The procedure was repeated following the same steps on the other side.
Peritoneal blockProcedure or surgery
before giving an incision for the ports, 20 ml of 0.25% bupivacaine will be infiltrated subcutaneously over the port sites (6 ml will be infiltrated around each midline port site and 4 ml will be infiltrated around at the lateral port sites) and at the end of surgery and before the removal of trocars, 20 ml of 0.25% bupivacaine diluted in normal saline will be instilled by the surgeon intraperitoneally at gallbladder bed and under domes of both diaphragms under direct vision with a separate catheter passed through one of the trocars.. The pressure of the gas insufflation was kept within 10-12 mm Hg in all patients. At the end of surgery, CO2 was evacuated, and intraperitoneal anesthetic solution was left in situ.
| Study group | Role | What they receive |
|---|---|---|
| Group A (RLB block) | Active comparator | Ultrasound-guided RLB block will be performed under strict aseptic precautions with patient turned to the lateral position. Receives: Procedure: retrolaminar block |
| Group B (Peritoneal block) | Active comparator | Peritoneal block will be performed under strict aseptic precautions before giving an incision for the ports, and at the end of surgery and before the removal of trocars Receives: Procedure: Peritoneal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic request
The time of the first analgesic request for pethidine will be recorded.
Measured: [Time Frame: Up to 24 hours after the procedure]
Secondary outcomes (5)
Visual analogue score (VAS) for pain assessment
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 24 hours after the procedure.
Measured: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
The amount of pethidine consumption given as a rescue analgesia to patients will be measured all over the 24 hours.
Measured: Up to 24 hours after the procedure
Heart rate (HR)
HR will be recorded every 30min till the end of the procedure
Measured: Up to the end of the procedure
Mean arterial pressure (MAP)
MAP will be recorded every 30min till the end of the procedure.
Measured: Up to the end of the procedure
.Adverse effects
Nausea, vomiting, hematoma, or allergic reactions will be recorded.
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start21 May 2023
- Primary completion20 Feb 2024
- Study completion15 Mar 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 Laparoscopic CholecystectomyStudies 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
- Model description
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hazem abdelmaksood EL-deeb, Mansoura University
- Investigators
- Amany H EL-Deeb, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755815
- Sponsor's protocol ID
- RLB Block for cholecystectomy
- Status last verified
- May 2025
- First submitted
- 23 Feb 2023
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
PubMed 36307755Funk RD, Hilliard P, Ramachandran SK. Perioperative opioid usage: avoiding adverse effects. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):32S-39S. doi: 10.1097/PRS.0000000000000680.
PubMed 25255004Gupta M, Naithani U, Singariya G, Gupta S. Comparison of 0.25% Ropivacaine for Intraperitoneal Instillation v/s Rectus Sheath Block for Postoperative Pain Relief Following Laparoscopic Cholecystectomy: A Prospective Study. J Clin Diagn Res. 2016 Aug;10(8):UC10-5. doi: 10.7860/JCDR/2016/18845.8309. Epub 2016 Aug 1.
PubMed 27656533Kamel AAF, Elhossieny KM, Hegab AS, Salem DAE. Ultrasound-guided Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy. Pain Physician. 2022 Sep;25(6):E795-E803.
PubMed 36122260Khandelwal H, Parag K, Singh A, Anand N, Govil N. Comparison of Subcostal Transversus Abdominis Block with Intraperitoneal Instillation of Levobupivacaine for Pain Relief after Laparoscopic Cholecystectomy: A Prospective Study. Anesth Essays Res. 2019 Jan-Mar;13(1):144-148. doi: 10.4103/aer.AER_3_19.
PubMed 31031495Mishra PK, Mani S, Singh RB. Evaluating the Efficacy of Pre-incisional Infiltration and Intraperitoneal Instillation of a Local Anesthetic Agent on Postoperative Analgesia and Hemodynamics in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia. Cureus. 2022 Mar 8;14(3):e22977. doi: 10.7759/cureus.22977. eCollection 2022 Mar.
PubMed 35415034Pizzi LT, Toner R, Foley K, Thomson E, Chow W, Kim M, Couto J, Royo M, Viscusi E. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012 Jun;32(6):502-14. doi: 10.1002/j.1875-9114.2012.01101.x. Epub 2012 May 8.
PubMed 22570188
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Retrolaminar Block Versus Intraperitoneal Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Cholecystectomy: Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05755815
- Acronym / sponsor ID
- RLB Block for cholecystectomy
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- retrolaminar block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 May 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 6 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.
Although laparoscopic cholecystectomy is a minimally invasive surgery, it causes moderate-severe pain. The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating the differences between the two techniques. It is hypothesized that retrolaminar block will be comparable to peritoneal block as a promising effective alternative for analgesia for in laparoscopic cholecystectomy surgeries with fewer side effects.
Detailed description
Laparoscopic cholecystectomy (LC) provides many advantages as less pain, shorter hospital stay, and earlier recovery, and it is a cost-effective procedure. Although it is a minimally invasive surgery, it causes moderate-severe pain. Pain has several sources but mostly visceral pain caused by tissue trauma during gall bladder resection is the most predominant component. Acute pain after laparoscopic cholecystectomy does not match pain after other laparoscopic surgeries because of its complexity, so proper management of pain should be procedure-specific and multimodal. Many analgesic interventions with different mechanisms have been studied for their effects on pain relief after laparoscopic cholecystectomy. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. Ultrasound-guided retrolaminar block is a recent modified paravertebral technique for analgesia in thoracoabdominal procedures with a local anesthetic injected at the retrolaminar site. It has the advantage of being safe and easy compared with traditional thoracic epidural analgesia. It has a decreased incidence of complications such as hypotension, pleural disorder, and nerve injury.Intraperitoneal local anaesthetic administration has been used as a method for reducing postoperative pain. Intraperitoneal local anaesthetics acts on visceral nociceptors of peritoneum.Therefore, this study will be conducted to evaluate efficacy and safety of ultrasound guided retrolaminar block for postoperative analgesia in laparoscopic cholecystectomy surgery in comparison to intraperitoneal local anaesthetic administration.
Aim of the Study:
The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating the differences between the two techniques. It is hypothesized that retrolaminar block will be comparable to peritoneal block as a promising effective alternative for analgesia for in laparoscopic cholecystectomy surgeries with fewer side effects.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with time to first analgesic request as the primary outcome. Using the results published by ahmed et al 2021 with the mean time to first analgesic request in intraperitoneal instillation group was (2.88 ± 0.33 hours). Using a two-sided two-sample unequal-variance t-test., sample size of 54 patients is needed to achieve 90% power to detect 10 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. A 10% drop out is considered, so a total of 60 patients will be enrolled (30 in each group) in this study
Methods:
The study will be conducted in Mansoura university hospital on sixty patients Who is Scheduled for laparoscopic cholecystectomy.They will be randomly assigned to two equal groups (retrolaminar group and peritoneal group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent. Patient demographic data including age, sex and body weight will be recorded. A written informed consent will be obtained from all study subjects after ensuring confidentiality. The study protocol will be explained along with VAS to all patients after enrollment into the study. In both groups, the block will be under strict aseptic conditions after patient intubation and before skin incision.
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS(Statistical Package for the Social Sciences) program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± SD (Standard deviation)and compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range) and compared with the Mann-Whitney U test. Repeated measures ANOVA will be used for comparisons within the same group. Categorical data will be presented as number (percentage) and compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.Conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Group A (RLB block) | Active comparator | Procedure: retrolaminar blockUltrasound-guided RLB block will be performed under strict aseptic precautions with patient turned to the lateral position. |
| Group B (Peritoneal block) | Active comparator | Procedure: Peritoneal blockPeritoneal block will be performed under strict aseptic precautions before giving an incision for the ports, and at the end of surgery and before the removal of trocars |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) 1 or 2 patients.
- Scheduled for laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
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 |
|---|---|---|
| retrolaminar blockA high-frequency 12 MHz linear ultrasound probe will be used, patients will receive bilateral ultrasound-guided retrolaminar plane block with 20 mL of bupivacaine 0.25%. Their spines will be palpated from the vertebra prominens caudally to T7 and point will be marked to identify the spinous processes, which will be confirmed by ultrasound through counting from T12 with the characteristic last rib attached to its transverse process upward to the T7 lamina. The linear high frequency transducer (6-13 MHz) will be placed in the parasagittal plane one cm lateral to the midline. The needle will be inserted in the in-plane view of the ultrasound probe and will be advanced from downward to upward to target the T7 posterior lamina surface at an angle of 90˚ to the skin until the needle tip will be contacted the posterior surface of targeted lamina . After negative aspiration, 20 mL of bupivacaine 0.25% will be injected. The procedure was repeated following the same steps on the other side. | Procedure or surgery | Group A (RLB block) |
| Peritoneal blockbefore giving an incision for the ports, 20 ml of 0.25% bupivacaine will be infiltrated subcutaneously over the port sites (6 ml will be infiltrated around each midline port site and 4 ml will be infiltrated around at the lateral port sites) and at the end of surgery and before the removal of trocars, 20 ml of 0.25% bupivacaine diluted in normal saline will be instilled by the surgeon intraperitoneally at gallbladder bed and under domes of both diaphragms under direct vision with a separate catheter passed through one of the trocars.. The pressure of the gas insufflation was kept within 10-12 mm Hg in all patients. At the end of surgery, CO2 was evacuated, and intraperitoneal anesthetic solution was left in situ. | Procedure or surgery | Group B (Peritoneal block) |
Primary outcome
First analgesic request
Time frame: [Time Frame: Up to 24 hours after the procedure]
The time of the first analgesic request for pethidine will be recorded.
5 secondary outcomes
Visual analogue score (VAS) for pain assessment
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
Time frame: Up to 24 hours after the procedure
Heart rate (HR)
Time frame: Up to the end of the procedure
Mean arterial pressure (MAP)
Time frame: Up to the end of the procedure
.Adverse effects
Time frame: Up to 24 hours after the procedure
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 20 May 2025.
- Results publication: PubMed 36307755Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
- Results publication: PubMed 25255004Funk RD, Hilliard P, Ramachandran SK. Perioperative opioid usage: avoiding adverse effects. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):32S-39S. doi: 10.1097/PRS.0000000000000680.
- Results publication: PubMed 27656533Gupta M, Naithani U, Singariya G, Gupta S. Comparison of 0.25% Ropivacaine for Intraperitoneal Instillation v/s Rectus Sheath Block for Postoperative Pain Relief Following Laparoscopic Cholecystectomy: A Prospective Study. J Clin Diagn Res. 2016 Aug;10(8):UC10-5. doi: 10.7860/JCDR/2016/18845.8309. Epub 2016 Aug 1.
- Results publication: PubMed 36122260Kamel AAF, Elhossieny KM, Hegab AS, Salem DAE. Ultrasound-guided Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy. Pain Physician. 2022 Sep;25(6):E795-E803.
- Results publication: PubMed 31031495Khandelwal H, Parag K, Singh A, Anand N, Govil N. Comparison of Subcostal Transversus Abdominis Block with Intraperitoneal Instillation of Levobupivacaine for Pain Relief after Laparoscopic Cholecystectomy: A Prospective Study. Anesth Essays Res. 2019 Jan-Mar;13(1):144-148. doi: 10.4103/aer.AER_3_19.
- Results publication: PubMed 35415034Mishra PK, Mani S, Singh RB. Evaluating the Efficacy of Pre-incisional Infiltration and Intraperitoneal Instillation of a Local Anesthetic Agent on Postoperative Analgesia and Hemodynamics in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia. Cureus. 2022 Mar 8;14(3):e22977. doi: 10.7759/cureus.22977. eCollection 2022 Mar.
- Results publication: PubMed 22570188Pizzi LT, Toner R, Foley K, Thomson E, Chow W, Kim M, Couto J, Royo M, Viscusi E. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012 Jun;32(6):502-14. doi: 10.1002/j.1875-9114.2012.01101.x. Epub 2012 May 8.
- 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. This study is not recruiting at the moment.
Amany H EL-Deeb, MD principal investigator
Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrolaminar block and Peritoneal block in people with Laparoscopic Cholecystectomy, run by Mansoura University at 1 site in Egypt.
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 6 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 20 May 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 Egypt. 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?
First analgesic request (time frame: [Time Frame: Up to 24 hours after the procedure]). 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 NCT05755815, 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 20 May 2025.