Skip to main content
Clinical Trials/NCT05341869
NCT05341869
Completed
Not Applicable

PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED PLACEBO CONTROLLED TRIAL

Erzincan Military Hospital2 sites in 1 country166 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Erzincan Military Hospital
Enrollment
166
Locations
2
Primary Endpoint
visual analog scale (VAS) pain score
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
January 14, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Erzincan Military Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kemal GUNGORDUK

Medical Doctor, associate professor

Erzincan Military Hospital

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

Outcomes

Primary Outcomes

visual analog scale (VAS) pain score

Time Frame: up to 1 hour after the procedure

1 h postoperative visual analog scale (VAS) pain score

Secondary Outcomes

  • faces pain scale-revised score(up to 2,4,6,12 hours after the procedure)
  • the quality of postoperative recovery(Up to 24 hours after the procedure)

Study Sites (2)

Loading locations...

Similar Trials