Pain, AcuteNCT03693820
Gall Bladder Bed Infiltration Analgesia
A study testing the infiltration group in people with Pain, Acute, run by Alaa Mazy Mazy at 1 site in Egypt.
Trial summary
Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- the infiltration group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2018to 11 Jul 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled to undergo elective laparoscopic cholecystectomy.
- American Society of Anesthesiologists physical status (ASA) I or II.
Who cannot join
- Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
- Patient with spillage or cholelithiasis with known common bile duct pathology.
- Body Mass Index > 40 Kg/m2.
- Patient underlying severe systemic disease.
- Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastro-enterolgy surgical center, Mansoura University
Al Mansurah, Al-Dakahleia, 35516
About this study
Official title: The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.
Read the detailed description
Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes.
In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.
- Conditions
- Pain, Acute
- Being tested
- the infiltration group, the control group
- Keywords
- cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain
- Medical subject headings
- Acute Pain, Agnosia, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the infiltration groupDrug
- 15-20 ml periportal,
- 50 ml in gallbladder bed,
- The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
the control groupDrug
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
| Study group | Role | What they receive |
|---|---|---|
| the infiltration group | Active comparator | a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China). Receives: Drug: the infiltration group |
| the control group | Placebo comparator | the same technique but the 50 ml for gallbladder infiltration will be replaced by saline. Receives: Drug: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total postoperative analgesic consumption
ketorolac and morphine in mg .
Measured: postoperative, for 24 hours
Secondary outcomes (9)
The time to the first request of analgesia
hours
Measured: postoperative, for 24 hours
The intraoperative fentanyl requirements.
microgram
Measured: intraoperative
postoperative pain score: VAS
visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,
Measured: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
heart rate
beat/ minute
Measured: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
mean blood pressure
mmHg
Measured: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
incidence of vomiting
number
Measured: postoperatively, during the first 24 hours
the sleep quality
through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
Measured: postoperatively, after the first night.
Patient satisfaction regards analgesia:
using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
Measured: postoperative after 24 hour.
Surgeon satisfaction regards the technique:
using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.
Measured: postoperative within 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start10 Sep 2018
- Primary completion1 Jun 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mazy Mazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mazy Mazy, Mansoura University
- Investigators
- alaa mazy, MD, Study director, faculty of medicine, Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693820
- Sponsor's protocol ID
- MS.18.09.277
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03693820
- Acronym / sponsor ID
- MS.18.09.277
- Conditions
- Pain, Acute
- Keywords
- cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alaa Mazy MazyUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 3 Oct 2018 (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.
Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.
Detailed description
Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes.
In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the infiltration group | Active comparator | Drug: the infiltration groupa cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China). |
| the control group | Placebo comparator | Drug: the control groupthe same technique but the 50 ml for gallbladder infiltration will be replaced by saline. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Scheduled to undergo elective laparoscopic cholecystectomy.
- American Society of Anesthesiologists physical status (ASA) I or II.
Key exclusion criteria (5 listed)
- Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
- Patient with spillage or cholelithiasis with known common bile duct pathology.
- Body Mass Index > 40 Kg/m2.
- Patient underlying severe systemic disease.
- Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.
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 |
|---|---|---|
| the infiltration group* 15-20 ml periportal, * 50 ml in gallbladder bed, * The rest (about 150 ml in 70 Kg patient) will be intraperitoneal | Drug | the infiltration group |
| the control groupthe 50 ml prepared for gallbladder bed infiltration will be replaced by saline. | Drug | the control group |
Primary outcome
The total postoperative analgesic consumption
Time frame: postoperative, for 24 hours
ketorolac and morphine in mg .
9 secondary outcomes
The time to the first request of analgesia
Time frame: postoperative, for 24 hours
The intraoperative fentanyl requirements.
Time frame: intraoperative
postoperative pain score: VAS
Time frame: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
heart rate
Time frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
mean blood pressure
Time frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
incidence of vomiting
Time frame: postoperatively, during the first 24 hours
the sleep quality
Time frame: postoperatively, after the first night.
Patient satisfaction regards analgesia:
Time frame: postoperative after 24 hour.
Surgeon satisfaction regards the technique:
Time frame: postoperative within 1 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 18 Sep 2020.
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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.
alaa mazy, MD study director
faculty of medicine, Mansoura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the infiltration group in people with Pain, Acute, run by Alaa Mazy Mazy 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 5 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 18 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
The total postoperative analgesic consumption (time frame: postoperative, for 24 hours). 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 18 Sep 2020.