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Completed

NCT Number: NCT03790748

Regional Blocks of Gynecological Surgeries

This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.

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Key information

Conditions

Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Surgical ICU, and Pain Management, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II
  • Height(150-170 cm)

Exclusion criteria

  • patient refusal
  • hypersensitivity to local anesthetic drugs
  • bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).

Treatment and study plan

Standard Lumbar Epidural Technique

Procedure

Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

25G Dural Puncture Epidural Technique

Procedure

25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

27G Dural Puncture Epidural Technique

Procedure

27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

Primary outcomes

  1. incidence of bilateral sacral blockade

    Time frame: Up to 30 minutes after local anesthetic injection

    Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)

Secondary outcomes

  1. Onset of sensory blockade

    Time frame: Up to 30 minutes after local anesthetic injection

  2. Maximum achieved sensory level

    Time frame: Up to 30 minutes after local anesthetic injection

  3. Time to achieve the maximum sensory level

    Time frame: Up to 30 minutes after local anesthetic injection

  4. Onset of motor blockade

    Time frame: Up to 30 minutes after local anesthetic injection

  5. Time to complete motor block

    Time frame: Up to 30 minutes after local anesthetic injection

  6. Duration of sensory block

    Time frame: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia

    Time to two segmental dermatomes regression

  7. Duration of motor block

    Time frame: Assessed every 20 minutes after achieving Bromage 3 motor block

    Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1

  8. Duration of analgesia

    Time frame: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively

    Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished

  9. Number of epidural top-ups

    Time frame: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery

  10. Sedation score

    Time frame: Assessed every 20 minutes during the surgical procedure and postoperatively

  11. Hemodynamic parameters

    Time frame: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms

  12. Perioperative side effects

    Time frame: During surgical period up to 7 days post-operatively

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2019
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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