Post Operative PainNCT06970548
Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block
A study testing Levobupivacaine in people with Post Operative Pain, run by Sohag University at 1 site in Egypt.
Trial summary
Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 patients with American Society of Anesthesiologists (ASA) grade I to II, 20 to 65 years of age scheduled for Laparoscopic Sleeve Gastrectomy.
Who cannot join
- patient refusal.
- Chronic alcoholism
- Chronic opioid usage
- ASA Grade 4 or more
- Chronic kidney disease
- Chronic liver disease
Show all 9Show fewer
- Chronic obstructive pulmonary disease.
- Known allergy to study medications.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block In Patient Undergoing Bariatric Surgery
Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent . Most morbidly obese patients also have obstructive sleep apnea and associated with cardiac co-morbidities. Prolonged postoperative pain in them may lead to delay in early ambulation and performing deep breathing exercises.
Read the detailed description
Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent.
This this increases incidence of deep vein thrombosis and risk of pulmonary complications respectively. Because postoperative recovery is directly associated with the intensity and duration of pain, it is imperative to reduce the postoperative pain as early as possible. A substantial component of pain experienced by patients undergoing laparoscopic surgery is somatic pain arising from the port sites over the abdominal wall.
Many methods have been suggested for reducing the postoperative abdominal wall pain such as port site instillation of local anesthetics, patient-controlled analgesia (PCA), epidural catheterization, and use of non-steroidal anti-inflammatory drugs (NSAIDS). Opioid analgesics to counter immediate acute postoperative pain are known to cause postoperative nausea and vomiting (PONV).
The average reported incidence of PONV in immediate postoperative period in patients undergoing bariatric surgery is between 30 and 50% [5]. This contributes to increased costs, increased length of stay, increased perioperative morbidity, and prolonged overall recovery [6]. Systemically administered opioids also depress respiratory drive, level of consciousness, and supraglottic airway muscle tone resulting in hypoxia and hypercapnia.
The TransversusAbdominis Plane (TAP) block is a loco-regional analgesia technique that consists of infiltrating a local anesthetic solution between the plane of the transversus-abdominis muscle and the internal oblique muscle, laterally at the level of the triangle of Petit. The sensory nerves of the abdominal wall pass through this plane. This technique produces long-lasting analgesia, between 24-36 hours.
- Conditions
- Post Operative Pain
- Being tested
- Levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Dexamethazone
To evaluate efficacy of addition of dexamethasone to levopubivacaine in tranversusabdominis plane block (TAP) in postoperative pain management, postoperative analgesic consumption, and patient comfort after laparoscopic bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 20 patients received Ultrasound-guided (USG-TAP) block with 40 ml of 0.375% levobupivacaine plus 8ml dexamethasone. All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant.The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h. Receives: Drug: Levobupivacaine |
| Group B: Control Group | Active comparator | About 20 patients received only (USG-TAP) by 40 ml 0.375% levobupivacaine.All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant. The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h. Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Relief
Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.
Measured: from 0 hours to 6 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 posted14 May 2025
- Study start1 Jun 2022
- Primary completion20 May 2023
- Study completion1 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.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Samir Esmail, Sohag University
- Investigators
- Ahmed hamody Hassan, Principal investigator, Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970548
- Sponsor's protocol ID
- Bariatric surgery
- Status last verified
- May 2022
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block In Patient Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06970548
- Acronym / sponsor ID
- Bariatric surgery
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 14 May 2025 (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.
Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent . Most morbidly obese patients also have obstructive sleep apnea and associated with cardiac co-morbidities. Prolonged postoperative pain in them may lead to delay in early ambulation and performing deep breathing exercises.
Detailed description
Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent.
This this increases incidence of deep vein thrombosis and risk of pulmonary complications respectively. Because postoperative recovery is directly associated with the intensity and duration of pain, it is imperative to reduce the postoperative pain as early as possible. A substantial component of pain experienced by patients undergoing laparoscopic surgery is somatic pain arising from the port sites over the abdominal wall.
Many methods have been suggested for reducing the postoperative abdominal wall pain such as port site instillation of local anesthetics, patient-controlled analgesia (PCA), epidural catheterization, and use of non-steroidal anti-inflammatory drugs (NSAIDS). Opioid analgesics to counter immediate acute postoperative pain are known to cause postoperative nausea and vomiting (PONV).
The average reported incidence of PONV in immediate postoperative period in patients undergoing bariatric surgery is between 30 and 50% [5]. This contributes to increased costs, increased length of stay, increased perioperative morbidity, and prolonged overall recovery [6]. Systemically administered opioids also depress respiratory drive, level of consciousness, and supraglottic airway muscle tone resulting in hypoxia and hypercapnia.
The TransversusAbdominis Plane (TAP) block is a loco-regional analgesia technique that consists of infiltrating a local anesthetic solution between the plane of the transversus-abdominis muscle and the internal oblique muscle, laterally at the level of the triangle of Petit. The sensory nerves of the abdominal wall pass through this plane. This technique produces long-lasting analgesia, between 24-36 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: LevobupivacaineAbout 20 patients received Ultrasound-guided (USG-TAP) block with 40 ml of 0.375% levobupivacaine plus 8ml dexamethasone. All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant.The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h. |
| Group B: Control Group | Active comparator | Drug: LevobupivacaineAbout 20 patients received only (USG-TAP) by 40 ml 0.375% levobupivacaine.All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant. The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 patients with American Society of Anesthesiologists (ASA) grade I to II, 20 to 65 years of age scheduled for Laparoscopic Sleeve Gastrectomy.
Key exclusion criteria (9 listed)
- patient refusal.
- Chronic alcoholism
- Chronic opioid usage
- ASA Grade 4 or more
- Chronic kidney 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 |
|---|---|---|
| LevobupivacaineAlso: DexamethazoneTo evaluate efficacy of addition of dexamethasone to levopubivacaine in tranversusabdominis plane block (TAP) in postoperative pain management, postoperative analgesic consumption, and patient comfort after laparoscopic bariatric surgery. | Drug | Group A, Group B: Control Group |
Primary outcome
Postoperative Pain Relief
Time frame: from 0 hours to 6 hours after the procedure
Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.
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 14 May 2025.
- 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.
Ahmed hamody Hassan principal investigator
Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag 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 Levobupivacaine in people with Post Operative Pain, run by Sohag 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 1 inclusion and 9 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 14 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?
Postoperative Pain Relief (time frame: from 0 hours to 6 hours after the procedure). 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 14 May 2025.