Quality of RecoveryNCT06155968
Evaluating The Quality of Recovery After Elective Cesarean Section
A study testing QL block and PCA in people with Quality of Recovery and Elective Cesarean Section, run by Ain Shams University at 1 site in Egypt.
Trial summary
Adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth. This study will explore the effect of two different methods for pain management on the quality of recovery of pregnant women undergoing cesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery, Elective Cesarean Section, Quadratus Lumborum Block
- What is being tested?
- QL block and PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 May 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status classification ΙΙ; and scheduled for elective cesarean section using a low transverse Pfannenstiel incision with spinal anesthesia.
Who cannot join
- (1) major hepatic, renal, or cardiovascular disease; (2) local infection; (3) bleeding disorder; (4) any contraindication for spinal anesthesia; or (5) known allergy to any drug used in the study (6) refusal to participate in the study (7) BMI > 35 (8) had opioid dependence (9) chronic analgesic usage (10) inability to use patient controlled analgesia (PCA) device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating The Quality of Recovery After Elective Cesarean Section Using ObsQoR-10, A Comparative Study Between Two Modalities for Pain Control.
Adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth. This study will explore the effect of two different methods for pain management on the quality of recovery of pregnant women undergoing cesarean section
Read the detailed description
- Type of Study: RCT
- Study Setting: Obstetric theatre at Ain Shams University Hospital
- Study Period :6 months
As per routine hospital practice, the pre-anesthetic assessment is performed, two 18 G peripheral cannula are inserted and 1 mg of granisetron and 50 mg of ranitidine are administered intravenously (IV) as premedications one hour before the operation, and 10 mL/kg of Ringer's lactate solution was infused for 15 minutes as a preload. All the study participants received a standard spinal anesthetic consisting of 10-12 mg of 0.5% hyperbaric bupivacaine.
The patients will be monitored using electrocardiography, non-invasive blood pressure measurement and pulse oximetry (SpO2). Spinal injection will be performed under aseptic technique in the sitting position at L3-L4 or L4-L5 intervertebral space using a 27-G Quincke needle.
The patients will be laid down in a supine position and oxygen therapy will be initiated at a rate of 6 L/min via a facemask throughout the procedure.
The level of sensory block will be confirmed using sensation to cold, the accepted level for initiation of the surgery will be at T4-5level.
The motor block will be monitored using Modified Bromage scale. The blood pressure, heart rate will be monitored. If the systolic blood pressure reduced to 20% below the baseline or less than 90 mmHg, 5 mg ephedrine was administered intravenously. Moreover, if the heart rate slowed to 50 beats/min or less, 0.5 mg atropine was administered intravenously.
After the completion of surgery, the sealed opaque envelope containing the group allocation was opened by the attending anaesthesia resident (who was not a part of the study) to decide the mode of analgesia the patient shall receive.
In group QL: The parturients will be positioned in left lateral decubitus position. The back is cleaned with chlorhexidine gluconate solution and is draped with sterile drapes. The block is given using 21 G, 100 mm long (B Braun Stimuplex®A) insulated blunt tip needles. Patients will receive bilateral ultrasonography (USG) guided block with 20 ml of 0.25 % bupivacaine on each side. The block is performed by anaesthesia consultants having experience of 5 years in ultrasound guided blocks. The procedure will be performed using aseptic technique (gown, gloves, facemask and protective sheath for the ultrasound probe).
The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles.
In the PCA group: the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min.
- Conditions
- Quality of Recovery, Elective Cesarean Section, Quadratus Lumborum Block, Patient Controlled Analgesia
- Being tested
- QL block, PCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL blockProcedure or surgery
The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles..
PCADrug
the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min
| Study group | Role | What they receive |
|---|---|---|
| PCA group | Active comparator | : the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min. Receives: Drug: PCA |
| QL block group | Active comparator | . Patients will receive bilateral ultrasonography (USG) guided block with 20 ml of 0.25 % bupivacaine on each side. The block is performed by anaesthesia consultants having experience of 5 years in ultrasound guided blocks. The procedure will be performed using aseptic technique (gown, gloves, facemask and protective sheath for the ultrasound probe).
The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles. Receives: Procedure: QL block |
What is being measured
The primary outcome is the main question the study is designed to answer.
ObsQor-10 score
compare the total ObsQor-10 score in both groups to determine which pain management intervention yields a better outcome.
Measured: 24 hours postoperative
Secondary outcomes (1)
validation of ObsQoR-10
psychometric validation of the ObsQoR-10 score in a subset of Egyptian women undergoing elective cesarean section.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Dec 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Haggag, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155968
- Sponsor's protocol ID
- FMASU R310/2023
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Quality of Recovery After Elective Cesarean Section Using ObsQoR-10, A Comparative Study Between Two Modalities for Pain Control.
- ClinicalTrials.gov ID
- NCT06155968
- Acronym / sponsor ID
- FMASU R310/2023
- Conditions
- Quality of Recovery, Elective Cesarean Section, Quadratus Lumborum Block, Patient Controlled Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 5 Dec 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.
Adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth. This study will explore the effect of two different methods for pain management on the quality of recovery of pregnant women undergoing cesarean section
Detailed description
- Type of Study: RCT
- Study Setting: Obstetric theatre at Ain Shams University Hospital
- Study Period :6 months
As per routine hospital practice, the pre-anesthetic assessment is performed, two 18 G peripheral cannula are inserted and 1 mg of granisetron and 50 mg of ranitidine are administered intravenously (IV) as premedications one hour before the operation, and 10 mL/kg of Ringer's lactate solution was infused for 15 minutes as a preload. All the study participants received a standard spinal anesthetic consisting of 10-12 mg of 0.5% hyperbaric bupivacaine.
The patients will be monitored using electrocardiography, non-invasive blood pressure measurement and pulse oximetry (SpO2). Spinal injection will be performed under aseptic technique in the sitting position at L3-L4 or L4-L5 intervertebral space using a 27-G Quincke needle.
The patients will be laid down in a supine position and oxygen therapy will be initiated at a rate of 6 L/min via a facemask throughout the procedure.
The level of sensory block will be confirmed using sensation to cold, the accepted level for initiation of the surgery will be at T4-5level.
The motor block will be monitored using Modified Bromage scale. The blood pressure, heart rate will be monitored. If the systolic blood pressure reduced to 20% below the baseline or less than 90 mmHg, 5 mg ephedrine was administered intravenously. Moreover, if the heart rate slowed to 50 beats/min or less, 0.5 mg atropine was administered intravenously.
After the completion of surgery, the sealed opaque envelope containing the group allocation was opened by the attending anaesthesia resident (who was not a part of the study) to decide the mode of analgesia the patient shall receive.
In group QL: The parturients will be positioned in left lateral decubitus position. The back is cleaned with chlorhexidine gluconate solution and is draped with sterile drapes. The block is given using 21 G, 100 mm long (B Braun Stimuplex®A) insulated blunt tip needles. Patients will receive bilateral ultrasonography (USG) guided block with 20 ml of 0.25 % bupivacaine on each side. The block is performed by anaesthesia consultants having experience of 5 years in ultrasound guided blocks. The procedure will be performed using aseptic technique (gown, gloves, facemask and protective sheath for the ultrasound probe).
The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles.
In the PCA group: the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA group | Active comparator | Drug: PCA: the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min. |
| QL block group | Active comparator | Procedure: QL block. Patients will receive bilateral ultrasonography (USG) guided block with 20 ml of 0.25 % bupivacaine on each side. The block is performed by anaesthesia consultants having experience of 5 years in ultrasound guided blocks. The procedure will be performed using aseptic technique (gown, gloves, facemask and protective sheath for the ultrasound probe). The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status classification ΙΙ; and scheduled for elective cesarean section using a low transverse Pfannenstiel incision with spinal anesthesia.
Key exclusion criteria (1 listed)
- (1) major hepatic, renal, or cardiovascular disease; (2) local infection; (3) bleeding disorder; (4) any contraindication for spinal anesthesia; or (5) known allergy to any drug used in the study (6) refusal to participate in the study (7) BMI > 35 (8) had opioid dependence (9) chronic analgesic usage (10) inability to use patient controlled analgesia (PCA) device.
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 |
|---|---|---|
| QL blockThe curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles.. | Procedure or surgery | QL block group |
| PCAthe PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min | Drug | PCA group |
Primary outcome
ObsQor-10 score
Time frame: 24 hours postoperative
compare the total ObsQor-10 score in both groups to determine which pain management intervention yields a better outcome.
1 secondary outcome
validation of ObsQoR-10
Time frame: 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 5 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL block and PCA in people with Quality of Recovery and Elective Cesarean Section, run by Ain Shams 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 1 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 5 Aug 2024. 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?
ObsQor-10 score (time frame: 24 hours postoperative). 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 5 Aug 2024.