Anesthesia, LocalNCT04748224
Dexmedetomidine as an Adjuvant to Local Anesthesia in Quadratus Lumborum Block After Cesarean Delivery
A study testing Bupivacaine 0.25% Injectable Solution and bupivacaine plus dexmedetomidine in people with Anesthesia, Local, run by Cairo University at 2 sites in Egypt.
Trial summary
Postoperative pain is considered one of the major problems after abdominal operations, so proper pain control is one of the main issues in clinical practice. Cesarean section (CS.) is one of the most common abdominal surgeries and the use of CS. worldwide has increased to unprecedented levels. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Bupivacaine 0.25% Injectable Solution and bupivacaine plus dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Feb 2020to 1 Mar 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for cesarean section under spinal anesthesia.
- Normal uncomplicated pregnancies (ASA II).
- BMI 18.5 to 34.9 kg/m2
Who cannot join
- Patient refusal.
- ASA III - IV patients.
- Coagulation disorders.
- Skin lesions or infection at site of proposed needle.
- Known allergy to any of study drugs.
- inability to comprehend or use the verbal rating pain scoring system
Show all 9Show fewer
- Difficulty in Ultrasonographic identification.
- Opioid abuse.
- BMI > 35 Kg/m2.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Cairo University
Cairo, 11956
Faculty of Medicine
Cairo, 11956
About this study
Official title: Evaluation of the Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Quadratus Lumborum Block After Cesarean Delivery: A Randomized Controlled Trial.
Postoperative pain is considered one of the major problems after abdominal operations, so proper pain control is one of the main issues in clinical practice. Cesarean section (CS.) is one of the most common abdominal surgeries and the use of CS. worldwide has increased to unprecedented levels. Effective postoperative analgesia enhances early recovery of the delivered mother, early ambulation, breast feeding and decreases the risk of postoperative thromboembolism. Therefore, Opioids are prescribed routinely for postoperative pain control, but they have many adverse effects such as nausea, vomiting, constipation, excessive sedation, dizziness, respiratory depression, and addiction, so it is important to practice alternative opioid sparing analgesic approaches. Recently, QL block is considered one of the perioperative pain management techniques used in patients undergoing various pelvi-abdominal surgeries. Quadratus Lumborum block inhibits both pain components (somatic and visceral) as a result of local anesthetic spread to the paravertebral spaceA study has been published comparing the analgesic efficacy between QLB and TAP block after cesarean section and proved that QL block II is more effective than TAP Block regarding pain relief and duration of action after CS. Also, Many studies have been published and prove that Combination of adjuvants like (fentanyl, clonidine and MgSo4,etc.) to local anesthetics agents helps in prolonging the analgesic effect and decrease 24hours opiate consumption.one of these adjuvants which used extensively in the regional techniques is dexmedetomidine, which is a selective alpha-2 adrenergic agonist. The optimal dosage of dexmedetomidine to be added to local anesthetics still remains unclear, but in other studies the dose of 0.5 μg/kg is widely used with no postoperative complications.
in this double blinded randomized controlled trial, the investigators compare the analgesic efficacy of adding dexmedetomidine to local anesthetic in quadratus lumborum block and their role in reduction postoperative opioid consumption after cesarean section
Read the detailed description
Using a computer-generated randomization schedule, fifty patients will be randomly assigned into two equal groups: group A (bupivacaine only; n=25) and group B (bupivacaine plus dexmedetomidine; n=25).
All participants, investigators, care providers and outcome assessors will be blinded to the study group allocation.
The day Prior to surgery, all patients will have pre anesthesia check-up with routine and subjective investigations and explained about the Numerical Rating Scale (NRS) ranging from 0-10 (0 indicating no pain and 10 for severe intractable pain) The patients will be pre medicated by 40mg oral pantoprazole at night and in the morning of the surgery.
On arrival to the operating room, patients will be monitored by peripheral pulse oximetry, five-lead electrocardiogram and non-invasive blood pressure monitor. Two 18-gauge intravenous cannulae will be inserted in the nondominant arm and 1500 ml crystalloid will be infused as acoload plus ephedrine infusion 4mg/min. to prevent post spinal hypotension.
Random allocation of patients into one of two groups using concealed closed envelope method, the patients' envelope which contain the number of group will be opened and recorded in the data collection sheet as a number of group because the data collector will be blinded to the intervention on the patient, only the anesthetist knows each number is referring to which intervention.
Spinal anesthesia will be performed with the patient in the sitting position at the level of L2 to 3 or L3 to 4 intervertebral spaces using a 25-gauge Quincke Bevel type needle (Spinocan®, Braun Melsungen AG,Germany) with 10 mg of hyperbaric bupivacaine(AstraZeneca Pharmaceuticals, UK) and 25μ g of fentanyl. Patients will be placed in the supine position with left uterine displacement and a face-mask will be applied to deliver oxygen at rate of 6 L/minute.
Five minutes after spinal injection, Spinal anesthesia level will be assessed by loss of cold (ice cube) and touch (blunt pin) discrimination and will be considered successful if a bilateral sensory blockade to T4-T6 is established. Anesthesia and surgical management will be performed in the usual manner.
At the end of surgery, all patients will receive 1 gm of intravenous paracetamol. After the abdomen will be cleaned with surgical solution, covering the wound and while the patient is still fully monitored, the patient will be placed in the lateral decubitus position and the QLB will be performed.
A convex (5-8 MHz) ultrasound probe (Shenzhen Mindray BIO-Medical Electronics, Model: DP-20, China) with a protective sheath will be used after imaging depth and gain is adjusted. The procedure will be done under complete aseptic condition (facemask, gown, and gloves) after cleaning of the abdominal skin with antiseptic solution.
The probe will be placed in the mid axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall (transversus abdominis, internal oblique, and external oblique). Then, scan dorsally keeping the transverse orientation until observing that the transversus abdominus muscle became aponeurotic, and this aponeurosis will be followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle , followed by recognition of Shamrock pattern by viewing psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process (trifoliate).
Stimuplex® A 21G 100-mm needle (B. BRAUN, Melsungen AG, Germany) will be inserted in plane under real time US guidance from anterolateral to posteromedial direction via the abdominal wall. Two milliliters of 0.9% saline will be injected to visualize the solution spread (hydro dissection) to determine the optimal point of injection over the lumbar interfacial triangle.
Group A will be injected with 20 ml of 0. 25% bupivacaine in each side. (14) Group B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA).
Patients will be transferred to the post anesthesia care unit (PACU) and discharged from PACU when fully conscious, hemodynamically stable and pain free.
All patients will receive IV paracetamol 1gm every 8 hours. As a rescue analgesic, IV morphine (0.05 mg/kg) will be given when Numerical Rating Scale (NRS) > 3, maximum dose of morphine will be given 30 mg per day.
the following data will be recorded:
- Total morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery
- Numerical Rating Scale (NRS) ranging from 0-10 (0 indicating no pain and 10 for severe intractable pain) will be recorded and compared at 4,8,12, and 24h after surgery.
- Incidence of post-operative complications as nausea, vomiting or abdominal distension will also be recorded.
- Conditions
- Anesthesia, Local
- Being tested
- Bupivacaine 0.25% Injectable Solution, bupivacaine plus dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Also called marcaine
a local anesthetic drug
bupivacaine plus dexmedetomidineDrug
Also called Marcaine plus precedex
bupivacaine is a local anesthetic drug plus dexmedetomidine is a new generation highly selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative and analgesic sparing effects
| Study group | Role | What they receive |
|---|---|---|
| group A (bupivacaine only) | Active comparator | Group A will be injected with 20 ml of 0. 25% bupivacaine in each side Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| group B (bupivacaine plus dexmedetomidine) | Active comparator | Group B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA). Receives: Drug: bupivacaine plus dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of morphine consumption
Measure the total amount of morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery
Measured: up to 24 hours
Secondary outcomes (1)
Numerical Rating Scale
Numerical Rating Scale at rest (static), and on movement (dynamic) at 4, 8, 12, and 24 hours postoperatively.
it requires the patient to rate their pain on a defined scale from 0 to 10 where 0 is no pain and 10 is the worst pain imaginable
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start2 Feb 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed elaraby, Cairo University
- Investigators
- Nesrine M. El-Refai, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748224
- Sponsor's protocol ID
- MD-75-2020
- Status last verified
- Jul 2022
- First submitted
- 15 Jan 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Snell P, Hicks C. An exploratory study in the UK of the effectiveness of three different pain management regimens for post-cesarean section women. Midwifery. 2006; 22(3):249-61. 2. Betrán A, Ye J, Moller A, et al. The Increasing Trend in Cesarean Section Rates: Global, Regional and National Estimates: 2016;11(2) 3. Gadsden J, Hart S, Santos A. Post-cesarean delivery analgesia. Anesth Analg 2005; 101(5 Suppl): S62-S69. 4. Karlström A, Engström-Olofsson R, Norbergh K, et al. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs 2007; 36: 430-40. 5. Stephan B, Parsa F. Avoiding Opioids and Their Harmful Side Effects in the Postoperative Patient: Exogenous Opioids, Endogenous Endorphins, Wellness, Mood, and Their Relation to Postoperative Pain. Hawai'i journal of medicine & public health: a journal of Asia Pacific Medicine & Public Health. 2016 Mar; 75(3):63-7. 6.Mieszkowski M, Zawadzka E, Tuyakov B, et al. Evaluation of the effectiveness of the Quadratus Lumborum Block type I using ropivacaine in postoperative analgesia after a cesarean section - a controlled clinical study. Ginekologia Polska 2018; 89: 89-96. 7. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after cesarean section: a randomized controlled trial. Eur J Anesthesiol. 2015; 32: 812-8. 8. Blanco R, Ansari T, Riad W, et al. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016; 41: 757-62. 9. Singh R, Kumar N, Jain A, et al. Addition of clonidine to bupivacaine in transversus abdominis plane block prolongs postoperative analgesia after cesarean section. J Anesthesiol ClinPharmacol 2016; 32:501-4. 10. Sarvesh B, Shivaramu B, Sharma K, et al. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018; 12(4):809-813. 11.Kirksey M, Haskins S, Cheng J, et al. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015; 10(9). 12. Varshney A, Prabhu M, Periyadka B, et al. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anesthesiol Clin Pharmacol. 2019; 35(2):161-164. 13- Qianchuang S, Shuyan L, Huiying u, et.al. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block. A Systematic Review and Meta-analysis Clin J Pain. 2019 Apr; 35(4): 375-384. 14. Carline L, McLeod G, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anesth. 2016; 117(3):387-394. 15. Kılıç E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain AfterPercutaneous Nephrolithotomy. Turk J Anesthesiol Reanim. 2018; 46(4):272-275.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Quadratus Lumborum Block After Cesarean Delivery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04748224
- Acronym / sponsor ID
- MD-75-2020
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Feb 2021 (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 is considered one of the major problems after abdominal operations, so proper pain control is one of the main issues in clinical practice. Cesarean section (CS.) is one of the most common abdominal surgeries and the use of CS. worldwide has increased to unprecedented levels. Effective postoperative analgesia enhances early recovery of the delivered mother, early ambulation, breast feeding and decreases the risk of postoperative thromboembolism. Therefore, Opioids are prescribed routinely for postoperative pain control, but they have many adverse effects such as nausea, vomiting, constipation, excessive sedation, dizziness, respiratory depression, and addiction, so it is important to practice alternative opioid sparing analgesic approaches. Recently, QL block is considered one of the perioperative pain management techniques used in patients undergoing various pelvi-abdominal surgeries. Quadratus Lumborum block inhibits both pain components (somatic and visceral) as a result of local anesthetic spread to the paravertebral spaceA study has been published comparing the analgesic efficacy between QLB and TAP block after cesarean section and proved that QL block II is more effective than TAP Block regarding pain relief and duration of action after CS. Also, Many studies have been published and prove that Combination of adjuvants like (fentanyl, clonidine and MgSo4,etc.) to local anesthetics agents helps in prolonging the analgesic effect and decrease 24hours opiate consumption.one of these adjuvants which used extensively in the regional techniques is dexmedetomidine, which is a selective alpha-2 adrenergic agonist. The optimal dosage of dexmedetomidine to be added to local anesthetics still remains unclear, but in other studies the dose of 0.5 μg/kg is widely used with no postoperative complications.
in this double blinded randomized controlled trial, the investigators compare the analgesic efficacy of adding dexmedetomidine to local anesthetic in quadratus lumborum block and their role in reduction postoperative opioid consumption after cesarean section
Detailed description
Using a computer-generated randomization schedule, fifty patients will be randomly assigned into two equal groups: group A (bupivacaine only; n=25) and group B (bupivacaine plus dexmedetomidine; n=25).
All participants, investigators, care providers and outcome assessors will be blinded to the study group allocation.
The day Prior to surgery, all patients will have pre anesthesia check-up with routine and subjective investigations and explained about the Numerical Rating Scale (NRS) ranging from 0-10 (0 indicating no pain and 10 for severe intractable pain) The patients will be pre medicated by 40mg oral pantoprazole at night and in the morning of the surgery.
On arrival to the operating room, patients will be monitored by peripheral pulse oximetry, five-lead electrocardiogram and non-invasive blood pressure monitor. Two 18-gauge intravenous cannulae will be inserted in the nondominant arm and 1500 ml crystalloid will be infused as acoload plus ephedrine infusion 4mg/min. to prevent post spinal hypotension.
Random allocation of patients into one of two groups using concealed closed envelope method, the patients' envelope which contain the number of group will be opened and recorded in the data collection sheet as a number of group because the data collector will be blinded to the intervention on the patient, only the anesthetist knows each number is referring to which intervention.
Spinal anesthesia will be performed with the patient in the sitting position at the level of L2 to 3 or L3 to 4 intervertebral spaces using a 25-gauge Quincke Bevel type needle (Spinocan®, Braun Melsungen AG,Germany) with 10 mg of hyperbaric bupivacaine(AstraZeneca Pharmaceuticals, UK) and 25μ g of fentanyl. Patients will be placed in the supine position with left uterine displacement and a face-mask will be applied to deliver oxygen at rate of 6 L/minute.
Five minutes after spinal injection, Spinal anesthesia level will be assessed by loss of cold (ice cube) and touch (blunt pin) discrimination and will be considered successful if a bilateral sensory blockade to T4-T6 is established. Anesthesia and surgical management will be performed in the usual manner.
At the end of surgery, all patients will receive 1 gm of intravenous paracetamol. After the abdomen will be cleaned with surgical solution, covering the wound and while the patient is still fully monitored, the patient will be placed in the lateral decubitus position and the QLB will be performed.
A convex (5-8 MHz) ultrasound probe (Shenzhen Mindray BIO-Medical Electronics, Model: DP-20, China) with a protective sheath will be used after imaging depth and gain is adjusted. The procedure will be done under complete aseptic condition (facemask, gown, and gloves) after cleaning of the abdominal skin with antiseptic solution.
The probe will be placed in the mid axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall (transversus abdominis, internal oblique, and external oblique). Then, scan dorsally keeping the transverse orientation until observing that the transversus abdominus muscle became aponeurotic, and this aponeurosis will be followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle , followed by recognition of Shamrock pattern by viewing psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process (trifoliate).
Stimuplex® A 21G 100-mm needle (B. BRAUN, Melsungen AG, Germany) will be inserted in plane under real time US guidance from anterolateral to posteromedial direction via the abdominal wall. Two milliliters of 0.9% saline will be injected to visualize the solution spread (hydro dissection) to determine the optimal point of injection over the lumbar interfacial triangle.
Group A will be injected with 20 ml of 0. 25% bupivacaine in each side. (14) Group B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA).
Patients will be transferred to the post anesthesia care unit (PACU) and discharged from PACU when fully conscious, hemodynamically stable and pain free.
All patients will receive IV paracetamol 1gm every 8 hours. As a rescue analgesic, IV morphine (0.05 mg/kg) will be given when Numerical Rating Scale (NRS) > 3, maximum dose of morphine will be given 30 mg per day.
the following data will be recorded:
- Total morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery
- Numerical Rating Scale (NRS) ranging from 0-10 (0 indicating no pain and 10 for severe intractable pain) will be recorded and compared at 4,8,12, and 24h after surgery.
- Incidence of post-operative complications as nausea, vomiting or abdominal distension will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (bupivacaine only) | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionGroup A will be injected with 20 ml of 0. 25% bupivacaine in each side |
| group B (bupivacaine plus dexmedetomidine) | Active comparator | Drug: bupivacaine plus dexmedetomidineGroup B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for cesarean section under spinal anesthesia.
- Normal uncomplicated pregnancies (ASA II).
- BMI 18.5 to 34.9 kg/m2
Key exclusion criteria (9 listed)
- Patient refusal.
- ASA III - IV patients.
- Coagulation disorders.
- Skin lesions or infection at site of proposed needle.
- Known allergy to any of study drugs.
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionAlso: marcainea local anesthetic drug | Drug | group A (bupivacaine only) |
| bupivacaine plus dexmedetomidineAlso: Marcaine plus precedexbupivacaine is a local anesthetic drug plus dexmedetomidine is a new generation highly selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative and analgesic sparing effects | Drug | group B (bupivacaine plus dexmedetomidine) |
Primary outcome
total amount of morphine consumption
Time frame: up to 24 hours
Measure the total amount of morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery
1 secondary outcome
Numerical Rating Scale
Time frame: up to 24 hours
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 26 Jul 2022.
- Background1. Snell P, Hicks C. An exploratory study in the UK of the effectiveness of three different pain management regimens for post-cesarean section women. Midwifery. 2006; 22(3):249-61. 2. Betrán A, Ye J, Moller A, et al. The Increasing Trend in Cesarean Section Rates: Global, Regional and National Estimates: 2016;11(2) 3. Gadsden J, Hart S, Santos A. Post-cesarean delivery analgesia. Anesth Analg 2005; 101(5 Suppl): S62-S69. 4. Karlström A, Engström-Olofsson R, Norbergh K, et al. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs 2007; 36: 430-40. 5. Stephan B, Parsa F. Avoiding Opioids and Their Harmful Side Effects in the Postoperative Patient: Exogenous Opioids, Endogenous Endorphins, Wellness, Mood, and Their Relation to Postoperative Pain. Hawai'i journal of medicine & public health: a journal of Asia Pacific Medicine & Public Health. 2016 Mar; 75(3):63-7. 6.Mieszkowski M, Zawadzka E, Tuyakov B, et al. Evaluation of the effectiveness of the Quadratus Lumborum Block type I using ropivacaine in postoperative analgesia after a cesarean section - a controlled clinical study. Ginekologia Polska 2018; 89: 89-96. 7. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after cesarean section: a randomized controlled trial. Eur J Anesthesiol. 2015; 32: 812-8. 8. Blanco R, Ansari T, Riad W, et al. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016; 41: 757-62. 9. Singh R, Kumar N, Jain A, et al. Addition of clonidine to bupivacaine in transversus abdominis plane block prolongs postoperative analgesia after cesarean section. J Anesthesiol ClinPharmacol 2016; 32:501-4. 10. Sarvesh B, Shivaramu B, Sharma K, et al. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018; 12(4):809-813. 11.Kirksey M, Haskins S, Cheng J, et al. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015; 10(9). 12. Varshney A, Prabhu M, Periyadka B, et al. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anesthesiol Clin Pharmacol. 2019; 35(2):161-164. 13- Qianchuang S, Shuyan L, Huiying u, et.al. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block. A Systematic Review and Meta-analysis Clin J Pain. 2019 Apr; 35(4): 375-384. 14. Carline L, McLeod G, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anesth. 2016; 117(3):387-394. 15. Kılıç E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain AfterPercutaneous Nephrolithotomy. Turk J Anesthesiol Reanim. 2018; 46(4):272-275.
- 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.
Nesrine M. El-Refai, professor study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% Injectable Solution and bupivacaine plus dexmedetomidine in people with Anesthesia, Local, run by Cairo University at 2 sites 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 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
total amount of morphine consumption (time frame: up to 24 hours). 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 NCT04748224, which also lists 1 linked publication.
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 26 Jul 2022.