PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Para-cervical block

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mentese
    • Mugla, Mentese, Turkey, 48000
      • Mugla Sıtkı Kocman University Education and Research Hospital
  • Muğla
    • Menteşe, Muğla, Turkey, 48000
      • Kemal Güngördük

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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.	Procedure: Para-cervical block; Block of inferior hypogastric plexus with local anesthetic
Experimental: Study; 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.	Procedure: Para-cervical block; Block of inferior hypogastric plexus with local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS) pain score	1 h postoperative visual analog scale (VAS) pain score	up to 1 hour after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the quality of postoperative recovery	the quality of postoperative recovery according to the QoR-40 questionnaire scores at 24 hours after the surgical procedure	Up to 24 hours after the 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	up to 2,4,6,12 hours after the procedure

Collaborators and Investigators

• Sponsor: Erzincan Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 14, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MUGLA-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No