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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
QL block and PCA
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.

Egypt1 site
  • Ain shams university

    Cairo, 12245

Other trials in Egypt

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.

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 groups in NCT06155968
Study groupRoleWhat they receive
PCA groupActive 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 groupActive 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.

  1. 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)
  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.

  1. First posted5 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

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)
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

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.

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