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PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Para-cervical block
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

-Patients undergoing total type A laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy, salpingectomy

Exclusion Criteria:

  • age < 18 years
  • refusal to provide consent
  • inability to understand the study questionnaire
  • severe psychiatric or mental disorder
  • American Society of Anesthesiologists (ASA) physical status classification > III
  • history of regular narcotic use within 6 months of the surgery
  • conversion to laparotomy

Sites / Locations

  • Mugla Sıtkı Kocman University Education and Research Hospital
  • Kemal Güngördük

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Study

Arm Description

Prior to starting surgery after general anesthesia, the 10 mL of normal saline was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Prior to starting surgery after general anesthesia, thE 10 mL of 0.5% bupivacaine with epinephrine was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Outcomes

Primary Outcome Measures

visual analog scale (VAS) pain score
1 h postoperative visual analog scale (VAS) pain score

Secondary Outcome Measures

the quality of postoperative recovery
the quality of postoperative recovery according to the QoR-40 questionnaire scores at 24 hours after the surgical procedure
faces pain scale-revised score
Faces pain scale-revised score is an objective method of pain assessment in which facial expressions of the patient are assessed by the investigator

Full Information

First Posted
April 17, 2022
Last Updated
February 21, 2023
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05341869
Brief Title
PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY
Official Title
PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED PLACEBO CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Total hysterectomy is one of the most common surgical procedure in gynecology. The laparoscopic route for the performance of hysterectomies are on the rise [1]. The laparoscopic hysterectomy (TLH) procedure has several advantages over open surgery such as better cosmetic outcomes, faster recovery earlier return to normal activities and work [1-3]. Nonetheless, postoperative pain (PP) remains an issue that scuppers these advantages [1-3]. The incidence of PP after TLH has been reported to vary from 35% to 63% [4,5]. The origin of PP after laparoscopy is multifactorial and complex such as perioperative predicaments, including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the abdomen, and dissection of the pelvic region [6-7]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [8]. Further inquiry to intercept the advancement and decrease the severity of PP is prominent to further improve TLH. Women undergoing TLH experience two different pain characteristics including incisional pain and visceral pain in the first hour after the operation [6]. These pains were most intense 30 min after TLH, gradually decreasing thereafter for postoperative 72 hr [6]. High levels of acute postoperative pain (APP) are pertain with an increment risk of chronic postsurgical pain so control of these acute pains in the urgent postoperative period is vital for faster amelioration. Many attempts have been tried to control APP after THL, such as transverse abdominal plane blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and reduced port caliber [9-12]. Para-cervical bloc (PCB) is believed to block the Frankenhouser nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the vagina. Only two randomized studies have assessed the effect of PCB in THL, but several limitations such as the small sample size preclude drawing conclusions on PP after TLH. Thus, the primary goal of this randomized clinical trial was to investigate if PCB at the onset of surgery, as a part of enhanced recovery protocol, could improve patient recovery after THL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Prior to starting surgery after general anesthesia, the 10 mL of normal saline was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.
Arm Title
Study
Arm Type
Experimental
Arm Description
Prior to starting surgery after general anesthesia, thE 10 mL of 0.5% bupivacaine with epinephrine was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.
Intervention Type
Procedure
Intervention Name(s)
Para-cervical block
Intervention Description
Block of inferior hypogastric plexus with local anesthetic
Primary Outcome Measure Information:
Title
visual analog scale (VAS) pain score
Description
1 h postoperative visual analog scale (VAS) pain score
Time Frame
up to 1 hour after the procedure
Secondary Outcome Measure Information:
Title
the quality of postoperative recovery
Description
the quality of postoperative recovery according to the QoR-40 questionnaire scores at 24 hours after the surgical procedure
Time Frame
Up to 24 hours after the procedure
Title
faces pain scale-revised score
Description
Faces pain scale-revised score is an objective method of pain assessment in which facial expressions of the patient are assessed by the investigator
Time Frame
up to 2,4,6,12 hours after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Patients undergoing total type A laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy or salpingectomy Exclusion Criteria: age < 18 years refusal to provide consent inability to understand the study questionnaire severe psychiatric or mental disorder American Society of Anesthesiologists (ASA) physical status classification > III history of regular narcotic use within 6 months of the surgery conversion to laparotomy operation time > 90 min Additional procedures
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Education and Research Hospital
City
Mugla
State/Province
Mentese
ZIP/Postal Code
48000
Country
Turkey
Facility Name
Kemal Güngördük
City
Menteşe
State/Province
Muğla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

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PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

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