Postoperative PainLSGNCT05696886
The Effect of Intraoperative Tramadol on Postoperative Opioid
A study testing Pethidine and Tramadol with pethidine in people with Postoperative Pain, run by Mansoura University at 1 site in Egypt.
Trial summary
Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pethidine and Tramadol with pethidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with morbid obesity defined as a BMI of more than 40 or
- BMI less than 35 with at least one comorbidity and
- ages ranging from 16 to 65, were patients
Who cannot join
- Patients under the age of 16 or over 65,
- Those with severe GERD, leakage
- pregnancy, or
- inflammatory bowel disease,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Tramadol on Postoperative Opioid Requirements After Laparoscopic Sleeve Gastrectomy for Morbid Obese Patients (A Retrospective Multicentric Cohort Study)
Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. The study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after LSG for morbidly obese patients
Read the detailed description
This multicenter cohort research included patients with morbid obesity who had LSG between January 2021 and December 2022. The patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
- Conditions
- Postoperative Pain
- Being tested
- Pethidine, Tramadol with pethidine
- Keywords
- laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine
- Medical subject headings
- Pain, Postoperative, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PethidineDrug
Also called Group A
Group A received Pethidine alone in the period between January 2021 and December 2021
Tramadol with pethidineDrug
Also called Group B
Group B got Tramadol with pethidine in the period between January 2022 and December 2022
| Study group | Role | What they receive |
|---|---|---|
| Group A received Pethidine alone in the period between January 2021 and December 2021, | Active comparator | received Pethidine alone in the period between January 2021 and December 2021, while Receives: Drug: Pethidine |
| Group B got Tramadol with pethidine in the period between January 2022 and December 2022. | Active comparator | Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Receives: Drug: Tramadol with pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS of pain
the severity of pain
Measured: 48 hours postoperative
opioid requirement
the need of pethidine
Measured: one month
Secondary outcomes (1)
hospital stay
hospital stay
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman E Nakeeb, Principal investigator, Mansoura University, Gastrointestinal Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696886
- Sponsor's protocol ID
- R.23.01.2008
- Acronym
- LSG
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study protocol will be available for another researcher
Publications
Zeeni C, Aouad MT, Daou D, Naji S, Jabbour-Khoury S, Alami RS, Safadi BY, Siddik-Sayyid SM. The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery. Obes Surg. 2019 Dec;29(12):3800-3808. doi: 10.1007/s11695-019-04074-1.
PubMed 31286397Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j.soard.2022.03.002. Epub 2022 Mar 9.
PubMed 35422388Tian C, Lee Y, Oparin Y, Hong D, Shanthanna H. Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis. Pain Physician. 2021 Aug;24(5):345-358.
PubMed 34323436
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Tramadol on Postoperative Opioid Requirements After Laparoscopic Sleeve Gastrectomy for Morbid Obese Patients (A Retrospective Multicentric Cohort Study)
- ClinicalTrials.gov ID
- NCT05696886
- Acronym / sponsor ID
- LSG / R.23.01.2008
- Conditions
- Postoperative Pain
- Keywords
- laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Jan 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.
Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. The study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after LSG for morbidly obese patients
Detailed description
This multicenter cohort research included patients with morbid obesity who had LSG between January 2021 and December 2022. The patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
| Arm | Type | Receives |
|---|---|---|
| Group A received Pethidine alone in the period between January 2021 and December 2021, | Active comparator | Drug: Pethidinereceived Pethidine alone in the period between January 2021 and December 2021, while |
| Group B got Tramadol with pethidine in the period between January 2022 and December 2022. | Active comparator | Drug: Tramadol with pethidineGroup B got Tramadol with pethidine in the period between January 2022 and December 2022. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with morbid obesity defined as a BMI of more than 40 or
- BMI less than 35 with at least one comorbidity and
- ages ranging from 16 to 65, were patients
Key exclusion criteria (4 listed)
- Patients under the age of 16 or over 65,
- Those with severe GERD, leakage
- pregnancy, or
- inflammatory bowel disease,
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 |
|---|---|---|
| PethidineAlso: Group AGroup A received Pethidine alone in the period between January 2021 and December 2021 | Drug | Group A received Pethidine alone in the period between January 2021 and December 2021, |
| Tramadol with pethidineAlso: Group BGroup B got Tramadol with pethidine in the period between January 2022 and December 2022 | Drug | Group B got Tramadol with pethidine in the period between January 2022 and December 2022. |
Primary outcome
VAS of pain
Time frame: 48 hours postoperative
the severity of pain
opioid requirement
Time frame: one month
the need of pethidine
1 secondary outcome
hospital stay
Time frame: one month
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 25 Jan 2023.
- Results publication: PubMed 31286397Zeeni C, Aouad MT, Daou D, Naji S, Jabbour-Khoury S, Alami RS, Safadi BY, Siddik-Sayyid SM. The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery. Obes Surg. 2019 Dec;29(12):3800-3808. doi: 10.1007/s11695-019-04074-1.
- Results publication: PubMed 35422388Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j.soard.2022.03.002. Epub 2022 Mar 9.
- Results publication: PubMed 34323436Tian C, Lee Y, Oparin Y, Hong D, Shanthanna H. Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis. Pain Physician. 2021 Aug;24(5):345-358.
- mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. the study protocol will be available for another researcher
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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.
Ayman E Nakeeb principal investigator
Mansoura University, Gastrointestinal Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pethidine and Tramadol with pethidine in people with Postoperative Pain, 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 3 inclusion and 4 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 25 Jan 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 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?
VAS of pain (time frame: 48 hours postoperative). The study lists 2 primary outcomes in all. 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 NCT05696886, which also lists 3 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 25 Jan 2023.