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Postoperative Analgesia in Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT06010602
Recruitment Status : Completed
First Posted : August 24, 2023
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Gaziosmanpasa Research and Education Hospital

Study Description
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Brief Summary:

İn this study, planned to compare the post-operative analgesic efficacy of Ilioinguinal iliohypogastric (II-IH) nerve block and Quadratus lumborum III Block in elective cesarean section operations.

this study primary aim is; To compare and evaluate the first rescue analgesia requirement times after Quadratus lumborum III and II-IH Block for postoperative analgesia after elective cesarean section operations under spinal anesthesia.

Our secondary aims are:

  1. To compare the amount of total analgesic use in the first 24 hours in patients
  2. To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
  3. Comparing the side effects such as postoperative nausea and vomiting

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Quadratus lumborum block Procedure: İlioinguinal-İliohipogastric nerve block Not Applicable

Detailed Description:

Patients who underwent elective cesarean section under spinal anesthesia will be divided into two groups at the end of the operation, using the closed envelope randomization method as Quadratus lumborum III and II-IH nerve block. Spinal anesthesia will be applied to all patients who will undergo elective cesarean section. At the end of the operation, they will be taken to the postoperative block room. All blocks will be performed by the same anesthesiologist under USG guidance. 20 ml of 0.25% bupivacaine will be used in the blocks. All patients will be followed in the block room for 30 minutes after the block application. Patients with a Modified Aldret score above 8 will be sent to the service because they are under spinal anesthesia at the end of the operation.At the end of the operation, when the spinal level regresses to two dermatome levels, paracetamol 1gr IV will be administered to all patients for post-op analgesia.Postoperative analgesia was planned for the patients as paracetamol 4x1 gr. Tramadol hydrochloride 1mg/kg was planned as rescue analgesia in the ward for patients with NRS scores greater than 3 in their postoperative follow-up.

Patients 2.,4.,8.,12.,24. hours will be followed by an anesthesia assistant who is different from the researcher who applied the block and who is blind for the study. The patients' first rescue analgesia times, NRS scores, postoperative side effects, and total analgesic amounts used in 24 hours will be recorded.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK and ILIOINGUINAL -ILIOHIPOGASTRIC NERVE BLOCK IN CESAREAN SECTION OPERATIONS
Actual Study Start Date : May 1, 2023
Actual Primary Completion Date : December 1, 2023
Actual Study Completion Date : February 15, 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Quadratus lumborum block group
the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.
 Procedure: Quadratus lumborum block
For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.
Other Name: Intravenous analgesic medication
Active Comparator: İlioinguinal-İliohipogastric nerve block group
the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.
 Procedure: İlioinguinal-İliohipogastric nerve block
For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.
Other Name: Intravenous analgesic medication


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of first rescue analgesia [ Time Frame: 24 hour ]
    For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. The time of the first administration of tramadol hydrochloride for each patient will be compared.


Secondary Outcome Measures :
  1. comparing the amount of total analgesic use in the first 24 hours in patients [ Time Frame: 24 hours ]
    For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.The total tramadol consumption of patients within the first 24 hours will be compared.

  2. Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients [ Time Frame: 24 hours ]
    To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.

  3. Comparing side effects such as postoperative nausea and vomiting [ Time Frame: 24 hours ]
    To compare postoperative side effects such as nausea and vomiting within the first 24 hours.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 40
  • ASA 2 risk group
  • Patients at 37-41 weeks of pregnancy
  • undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

  • The patient does not accept the procedure.
  • Patients with a history of eclampsia and preeclampsia during pregnancy
  • local anesthetic allergy
  • Infection at the procedure site
  • Anticoagulant use with bleeding disorder
  • Chronic analgesia and opioid use
  • Mental, psychiatric and neurological problems
  • Patients with ASA 3 and above with a history of any chronic disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06010602


Locations
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Turkey
Gaziosmanpasa Research and Education Hospital
Istanbul, Turkey, 34000
Sponsors and Collaborators
Gaziosmanpasa Research and Education Hospital
Investigators
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Principal Investigator: serpil sehirlioglu Gaziosmanpasa Research and Education Hospital
More Information
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Publications of Results:

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Responsible Party: Gaziosmanpasa Research and Education Hospital
ClinicalTrials.gov Identifier: NCT06010602    
Other Study ID Numbers: GaziosmanpasaTREH47
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gaziosmanpasa Research and Education Hospital:
cesarean section
Quadratus lumborum III block
Ilioinguinal iliohypogastric block
analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs