Evaluating The Quality of Recovery After Elective Cesarean Section

NCT06155968 | Completed

• 1 other identifier: FMASU R310/2023
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Quality of Recovery; Elective Cesarean Section; Quadratus Lumborum Block; Patient Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• ObsQor-10 score

  compare the total ObsQor-10 score in both groups to determine which pain management intervention yields a better outcome.

  24 hours postoperative

Secondary Outcomes (1)

• validation of ObsQoR-10

  24 hours

Study Arms (2)

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.

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.

Procedure: QL block

Interventions

QL block PROCEDURE

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..

QL block group

PCA DRUG

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

PCA group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: parturient undergoing cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status classification ΙΙ; and scheduled for elective cesarean section using a low transverse Pfannenstiel incision with spinal anesthesia.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 12245, Egypt

Location

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 5, 2023
• Study Start: December 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

EG (1)